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Alco-Screen saliva alcohol test box, test strip and foil package
Alco Screen Saliva Alcohol Test
Alco Screen Saliva Alcohol Test

Alco Screen Saliva Alcohol Test (24/Box)

$39.95

CLIA Waived
FDA 510(k) Cleared
OTC Use

24 tests per box$1.66 per test

A visually read, semi-quantitative saliva alcohol test that estimates relative blood alcohol concentration at 0.00%, 0.02%, 0.04%, 0.08% and 0.30% BAC. Compare the test-pad color with the chart on the foil package at 2 minutes.

  • FDA 510(k) cleared under K121247, CLIA waived and cleared for over-the-counter use
  • Five-level BAC estimate using a saliva specimen and printed color chart
  • Wet the test pad for 5 seconds and interpret the color at 2 minutes
  • Contains 24 individually packaged, single-use test strips
Quantity Discounts
1-5 6-10 11+
$39.95 $36.75 $34.76

Alco-Screen Saliva Alcohol Test Overview

Alco-Screen is a visually read, semi-quantitative screening test used to estimate relative blood alcohol concentration (BAC) from a human saliva specimen. The single-use test pad changes from green-gray toward blue-gray in the presence of alcohol. At 2 minutes, compare the developed pad with the color blocks printed on the foil package to estimate BAC at 0.00%, 0.02%, 0.04%, 0.08% or 0.30%. Each box contains 24 individually packaged test strips.

CLIA Waived
FDA 510(k) K121247
OTC Use
24 Tests per Box

Features and Benefits

Five-level BAC estimateEstimates relative BAC at 0.00%, 0.02%, 0.04%, 0.08% and 0.30% using the color chart printed on the foil package.

Two-minute resultWet the test pad with saliva for 5 seconds, remove it and compare the color at 2 minutes.

Simple visual interpretationNo analyzer, calibration or additional reagent is required; match the developed pad to the printed color blocks.

FDA-cleared OTC useFDA decision summary K121247 identifies the device for over-the-counter use as well as in vitro diagnostic use.

CLIA waivedThe FDA categorization notification identifies the Chematics Alco-Screen Saliva Alcohol Test as waived under CLIA.

Individually packagedEach box contains 24 foil-packaged, single-use test strips and one instruction sheet.

Product Details

Reference
DS77C124
SKU
DTK-107002
FDA 510(k)
K121247
Package
24 Tests per Box

Specification Details
Brand Alco-Screen
Manufacturer Chematics, Inc.
Test format Single-use plastic strip with a reactive test pad
Test method Chromogenic, semi-quantitative, visually read color change
Analyte Alcohol in human saliva
Specimen Human saliva collected in a clean, dry cup
BAC levels 0.00%, 0.02%, 0.04%, 0.08% and 0.30%
Pad wetting time 5 seconds
Read time Compare the pad with the foil color chart at 2 minutes; results after 2 minutes 30 seconds may be inaccurate
Regulatory status FDA 510(k) cleared under K121247; 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

BAC Levels and Color Interpretation

The developed test-pad color must be compared with the color chart printed on the same foil package. Select the color block that most closely matches the pad at the specified read time.

Comparing an Alco-Screen saliva test strip with the BAC color chart
Compare the developed Alco-Screen test pad with the color chart printed on the same foil package at 2 minutes.
Printed BAC Level Interpretation
0.00% No color change; the pad matches the negative color block
0.02% Match the developed pad to the 0.02% color block on the foil package
0.04% Match the developed pad to the 0.04% color block on the foil package
0.08% Match the developed pad to the 0.08% color block on the foil package
0.30% Match the developed pad to the 0.30% color block on the foil package

Alco-Screen provides an estimate of relative BAC; it does not establish that a person is safe to operate a motor vehicle, machinery or other equipment. Results from this test may not be used for legal proceedings. Confirm a positive result using an acceptable evidentiary alcohol test.

How to Perform the Test

Wait before collecting salivaDo not place food, drink or any other material in the mouth for at least 15 minutes before testing. A sober person should perform and interpret the test.

Prepare and inspect the testAllow the sealed package to reach room temperature. Open it immediately before use and verify that the unused test pad is cream colored and no darker than the negative block.

Collect the saliva specimenSpit into a clean, dry collection cup. Collect enough saliva to completely wet the test pad and begin the test immediately.

Wet the test padPlace the test pad in the saliva for 5 seconds, remove it and start the timer immediately.

Compare the colorAt 2 minutes, compare the test pad with the color chart on the foil package and select the closest BAC level.

Respect the read windowDo not rely on a result read after 2 minutes 30 seconds because it may be inaccurate.

Important interpretation notice: Read the test under incandescent, fluorescent or indirect sunlight. Do not interpret it under mercury or sodium-vapor lighting. The package insert states that the test should not be interpreted by a person who is color-blind or visually impaired.

Testing Precautions and Limitations

Avoid alcohol vaporsThe pad is highly sensitive to alcohol. Perform the test in an area free from alcohol vapors, including vapors from ethanol-containing hand sanitizers.

Check oral conditionsDo not conduct the test when visible blood or sores are present in the mouth because the effect on test performance has not been evaluated.

Use saliva onlyThe FDA-cleared intended use is for human saliva. Do not market this configuration for testing beverages or other specimen types.

Confirm positive resultsUse an acceptable evidentiary alcohol test to confirm a positive screening result.

What Is Included?

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

Instruction sheetOne instruction sheet is supplied with each box.

Clean collection cup requiredA clean, dry saliva-collection cup is required but is not included with the standard 24-test box. Shop DTKUSA collection cups separately.

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

Storage and Handling

Store at 50–80°FKeep the tests between 50–80°F (10–27°C).

Do not freezeProtect the test from storage temperatures outside the labeled 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 Package Insert
FDA CLIA Waiver Notification
FDA 510(k) Decision Summary K121247
Alco-Screen Safety Data Sheet

Frequently Asked Questions

What does Alco-Screen measure?

Alco-Screen detects alcohol in human saliva and provides a semi-quantitative estimate of relative BAC at 0.00%, 0.02%, 0.04%, 0.08% or 0.30%.

Is Alco-Screen CLIA waived?

Yes. The FDA categorization notification for K121247 identifies the Chematics Alco-Screen Saliva Alcohol Test as CLIA waived. Laboratories must follow the FDA-cleared instructions to maintain waived status.

Is this test cleared for home or over-the-counter use?

Yes. FDA decision summary K121247 identifies this configuration for over-the-counter use.

How quickly should the result be read?

Compare the developed test pad with the color chart at 2 minutes. Results read after 2 minutes 30 seconds may be inaccurate.

How long should someone wait after eating or drinking?

Nothing should be placed in the mouth for at least 15 minutes before testing, including food and beverages.

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 legally or safely operate a motor vehicle, machinery or other equipment.

Can Alco-Screen results be used in legal proceedings?

No. The package insert states that results from this test may not be used for legal proceedings. Confirm a positive result with an acceptable evidentiary alcohol test.

Are saliva-collection cups included?

No. The standard package contains 24 individually packaged test strips and one instruction sheet. A clean, dry collection cup and a timer are required but not supplied. DTKUSA collection cups are available separately.

Can this strip be used to test beverages?

The FDA-cleared intended use is limited to human saliva. Beverage testing is not included in the product-specific package insert or FDA-cleared indication.

Is this the same product as Alco-Screen 02?

No. This Alco-Screen configuration estimates five BAC levels and is cleared under K121247. Alco-Screen 02 is a separate product with different instructions and a different FDA 510(k).

Need Collection Cups?

A clean, dry cup is required to collect the saliva specimen and is not included in the standard Alco-Screen box. DTKUSA collection cups are sold separately.

Shop Collection Cups

Additional information

Weight 1 lbs
Dimensions 7 × 4 × 2 in

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