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Alco-Screen 02 DOT-listed saliva alcohol test box with 0.02% BAC threshold

ALCO Screen 02 Saliva Alcohol Test- DOT Approved

$39.60

DOT-Listed ASD
CLIA Waived
FDA 510(k) Cleared

24 tests per box$1.65 per test

Qualitative saliva alcohol screening device that indicates whether relative blood alcohol concentration is at or above the 0.02% BAC threshold. Read the test at 4 minutes.

  • Listed by the U.S. Department of Transportation as an approved alcohol screening device
  • Distinct colored line indicates a relative BAC at or above 0.02%
  • FDA 510(k) cleared under K121256, CLIA waived and cleared for OTC use
  • Contains 24 individually packaged, single-use test strips
Quantity Discounts
1-5 6-10 11+
$39.60 $36.43 $34.45

Alco-Screen 02 Saliva Alcohol Test Overview

Alco-Screen 02 is a visually read, qualitative alcohol screening device for human saliva. When relative blood alcohol concentration is at or above 0.02% BAC, a distinct colored line develops across the reactive pad. The result is read at 4 minutes. Alco-Screen 02 is FDA 510(k) cleared, CLIA waived, cleared for over-the-counter use and listed by the U.S. Department of Transportation for DOT alcohol screening tests. Each box contains 24 individually packaged, single-use strips.

DOT-Listed ASD
CLIA Waived
FDA 510(k) K121256
24 Tests per Box

Features and Benefits

0.02% BAC thresholdProvides a qualitative positive or negative result at the 0.02% relative BAC threshold.

Four-minute resultRead the test at 4 minutes. Results interpreted after 5 minutes may be inaccurate.

DOT-listed screening deviceAlco-Screen 02 appears on the U.S. DOT list of approved alcohol screening devices for testing performed under 49 CFR Part 40.

Simple visual interpretationA distinct colored line indicates a relative BAC at or above 0.02%; no colored line indicates a result below 0.02%.

FDA-cleared and CLIA waivedFDA 510(k) K121256 covers the exact Alco-Screen 02 saliva alcohol test, and the test is categorized as CLIA waived.

OTC useThe FDA decision summary identifies this single-use, self-contained test for over-the-counter use.

Product Details

Reference
DS85C124DT
SKU
DTK-450800
FDA 510(k)
K121256
Package
24 Tests per Box

Specification Details
Brand Alco-Screen 02
Manufacturer Chematics, Inc.
Test format Single-use plastic strip with a reactive saliva test pad
Test method Qualitative, chromogenic, visually read color change
Analyte Ethyl alcohol in human saliva
Threshold Relative BAC at or above 0.02%
Pad wetting time 5 seconds
Read time Read at 4 minutes; results after 5 minutes may be inaccurate
Result type Qualitative positive or negative alcohol screening result
DOT status Listed alcohol screening device for DOT screening tests under 49 CFR Part 40
Regulatory status FDA 510(k) cleared under K121256; CLIA waived; over-the-counter use
Instrument requirement None
Storage 50–80°F (10–27°C); do not freeze
Package size 24 individually packaged tests per box

Understanding the Test Results

Positive screening resultA distinct colored line appears across the test pad, indicating a relative BAC at or above 0.02%. Confirm the result using the applicable evidentiary alcohol-testing procedure.

Negative screening resultNo colored line appears across the test pad, indicating a relative BAC below 0.02%.

Do not use a discolored stripThe unused pad should be cream colored. Do not use the test if a blue line is visible before the specimen is applied.

Alco-Screen 02 is an alcohol screening device, not an evidential confirmation device. It does not provide an exact BAC value and must not be used to determine whether someone can safely or legally operate a motor vehicle, machinery or heavy equipment. The package insert states that results may not be used as evidence in legal proceedings.

DOT-Regulated Testing Requirements

Screening use onlyUnder DOT rules, Alco-Screen 02 may be used only for the initial alcohol screening test. It is not an evidential breath-testing device.

Follow 49 CFR Part 40DOT-regulated testing must be performed by qualified personnel using the required DOT procedures, forms and documentation.

Apply saliva directlyFor U.S. DOT-mandated testing, saturate the reactive pad by applying saliva directly to the pad, immediately start the timer and follow the package insert.

Confirm applicable resultsFollow DOT requirements for confirmation of an initial alcohol screening result at or above 0.02% using an approved evidential breath-testing device.

DOT compliance notice: Inclusion on the DOT approved-device list does not by itself make every use compliant. DOT-regulated testing must follow the current requirements of 49 CFR Part 40, including operator qualification, test procedure, documentation and confirmation requirements.

How to Perform the Test

Observe the 15-minute waiting periodDo not place food, beverages, tobacco products, gum, mints or any other material in the mouth for at least 15 minutes before testing. Someone sober should perform the test.

Prepare and inspect the stripAllow the sealed test to reach room temperature. Open it immediately before use. The unused pad should be cream colored; discard it if a blue line is already visible.

Apply the saliva specimenFor DOT-mandated testing, apply saliva directly to the pad. For non-DOT testing, saliva may be collected in a clean, dry cup and used to completely wet the pad.

Wet the pad for 5 secondsSaturate the reactive pad with saliva for 5 seconds, remove it and start the timer immediately.

Read at 4 minutesCheck the pad for a distinct colored line at 4 minutes. Results interpreted after 5 minutes may be inaccurate.

Testing Precautions and Limitations

Avoid alcohol vaporsThe pad is highly sensitive to alcohol vapors. Test in an alcohol-free area and take precautions around ethanol-containing hand sanitizers and cleaning products.

Use appropriate lightingRead the test under incandescent, fluorescent or indirect sunlight. Do not interpret it under sodium-vapor lighting.

Visual interpretation requiredThe package insert states that visually impaired persons should not interpret this test.

Saliva specimen onlyThe FDA-cleared intended use is limited to human saliva. Do not use or market the device for other specimen types.

What Is Included?

Individually packaged test stripsEach foil package contains one single-use Alco-Screen 02 test strip.

Instruction sheetOne instruction sheet is supplied with each 24-test box.

Timer requiredA timer capable of tracking the four-minute read window is required but not included.

Cup for non-DOT collectionA clean, dry cup is required for the insert’s non-DOT collection method but is not included. Shop DTKUSA collection cups separately.

Storage and Handling

Store at 50–80°FKeep the tests between 50–80°F (10–27°C). DOT specifically cautions against storage above 80°F.

Do not freezeProtect the test from freezing and from temperatures outside the labeled storage range.

Keep sealed until useDo not open the foil package until immediately before testing, and do not use a damaged or unsealed package.

Check the expiration dateDo not use the test after the expiration date printed on the foil package.

Instructions and Regulatory Documents

Alco-Screen 02 Package Insert
FDA 510(k) Decision Summary K121256
U.S. DOT Approved Screening Devices

Frequently Asked Questions

What does Alco-Screen 02 detect?

It qualitatively detects ethyl alcohol in human saliva at a relative BAC threshold of 0.02%. It provides a positive or negative screening result, not an exact BAC measurement.

Is Alco-Screen 02 approved for DOT alcohol screening?

Alco-Screen 02 is listed by the U.S. Department of Transportation as an approved alcohol screening device. It may be used for DOT screening only when all applicable 49 CFR Part 40 requirements are followed.

Can Alco-Screen 02 be used for DOT confirmation testing?

No. It is an alcohol screening device only. DOT confirmation testing must be performed using an approved evidential breath-testing device and the required DOT procedure.

Is Alco-Screen 02 CLIA waived?

Yes. The exact Chematics Alco-Screen 02 Saliva Alcohol Test under K121256 is categorized as CLIA waived. Laboratories must follow the FDA-cleared instructions to maintain waived status.

Is the test cleared for over-the-counter use?

Yes. FDA decision summary K121256 identifies the device for over-the-counter use.

How quickly should the result be read?

Read the test at 4 minutes. Results interpreted after 5 minutes may be inaccurate.

What does a colored line mean?

A distinct colored line across the test pad is a positive screening result indicating a relative BAC at or above 0.02%. No colored line indicates a result below 0.02%.

Is a collection cup required?

For DOT-mandated testing, the insert directs the operator to apply saliva directly to the pad. For non-DOT testing, saliva may be collected in a clean, dry cup. Cups are not included; DTKUSA collection cups are available separately.

Can the result show that someone is safe to drive?

No. The package insert states that the test must not be used to determine whether someone can safely or legally operate a motor vehicle, machinery or heavy equipment.

Is this the same product as the five-level Alco-Screen test?

No. Alco-Screen 02 is a qualitative 0.02% threshold test cleared under K121256. The separate Alco-Screen product estimates five BAC levels and is cleared under K121247.

Need Collection Cups for Non-DOT Testing?

The package insert’s non-DOT collection method uses a clean, dry cup. Collection cups are not included with the standard Alco-Screen 02 box and are available separately.

Shop Collection Cups

Additional information

Weight 0.15 lbs
Dimensions 1.5 × 4.5 × 3 in

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