Accutest 6 Panel Drug Test Cassette Screen CLIA Waived- 25/Box (AMP / COC / THC / MET / OPI / PCP)

$143.75

CLIA Waived
FDA 510(k) Cleared
Professional Use

25 tests per box$5.75 per test

Professional six-panel urine drug-test cassette for the simultaneous qualitative screening of amphetamine, cocaine metabolite, marijuana metabolite, methamphetamine, opiates and phencyclidine. Read results at 5 minutes.

  • Screens AMP, COC, THC, mAMP/MET, OPI and PCP
  • CLIA-waived cassette for healthcare professionals and point-of-care sites
  • Three-drop procedure with no instrument or reagent preparation required
  • Internal procedural controls help verify adequate sample flow and correct technique
Quantity Discounts
1-5 6-10 11+
$143.75 $132.25 $125.06

ACCUTEST 6-Panel Drug Test Cassette Overview

The ACCUTEST DS56A is a professional, CLIA-waived urine cassette for the simultaneous qualitative screening of six drugs and drug metabolites. The test uses competitive-binding lateral-flow immunochromatography and requires no instrument. Its exact panel includes AMP, COC, THC, mAMP, OPI and PCP. Results are read at 5 minutes, and each box contains 25 test devices with disposable droppers.

CLIA Waived
FDA 510(k) Cleared
Professional Use
25 Tests per Box

Features and Benefits

Six-analyte screeningOne cassette screens AMP, COC, THC, mAMP/MET, OPI and PCP in human urine.

Results at 5 minutesInterpret the test at 5 minutes. The package insert states that results may be read for up to 4 hours after test initiation.

Simple cassette procedureAdd three full drops of urine to each sample well shown on the cassette and start the timer. Follow the supplied insert for the exact procedure.

No instrument requiredThe test is visually interpreted and does not require an analyzer or prepared reagents.

Internal procedural controlsControl lines help confirm sufficient sample volume, adequate membrane wicking and correct procedural technique.

Ready-to-use packageEach box contains 25 test devices, disposable droppers and a package insert.

Product Details

Reference
DS56A
SKU
DTK-106068
Device
DOA-1165
Package
25 Tests per Box

Specification Details
Brand ACCUTEST
Manufacturer ACON Laboratories, Inc.
Test format Six-panel, multi-line urine cassette
Test method Competitive-binding lateral-flow immunochromatographic assay
Sample Human urine
Sample volume Three full drops per sample well, approximately 100 µL per well
Result type Preliminary qualitative screening result
Read time Read at 5 minutes; results may be read for up to 4 hours after test initiation
Intended use Healthcare professionals, including professionals at point-of-care sites
Regulatory status CLIA waived; FDA 510(k) cleared professional device family under K020313
Storage 36–86°F (2–30°C); keep sealed and do not freeze

Drug Panel and Cutoff Levels

The DS56A / DOA-1165 configuration screens the following drugs and drug metabolites in human urine at the listed cutoff concentrations.

Drug or Drug Class Abbreviation Calibrator Cutoff
Amphetamine AMP d-Amphetamine 1,000 ng/mL
Cocaine metabolite COC Benzoylecgonine 300 ng/mL
Marijuana metabolite THC 11-nor-Δ9-THC-9-COOH 50 ng/mL
Methamphetamine mAMP/MET d-Methamphetamine 1,000 ng/mL
Opiates OPI Morphine 2,000 ng/mL
Phencyclidine PCP Phencyclidine 25 ng/mL

This test provides a preliminary qualitative screening result only. It does not determine impairment, administration route or the concentration of a drug in urine. A more specific analytical method must be used to confirm a preliminary positive result; GC/MS is identified in the package insert as the preferred confirmatory method.

How to Perform the Test

Prepare the materialsAllow the sealed test device, urine sample and any controls to reach 59–86°F (15–30°C).

Open the pouchRemove the cassette from the sealed pouch and use it as soon as possible. Place it on a clean, level surface.

Add the urine sampleHold the dropper vertically and add three full drops, approximately 100 µL, to each sample well shown on the cassette. Avoid air bubbles and follow the supplied package insert.

Start the timer and readRead the colored lines at 5 minutes. The insert states that results may be read for up to 4 hours after test initiation.

Understanding the Results

NegativeA control line and the corresponding test line appear. Any visible test line, even a faint line, is interpreted as negative.

Preliminary positiveThe control line appears, but no line appears in the test region for the applicable analyte. Confirm the result with a more specific analytical method.

InvalidNo control line appears. Review the procedure and repeat the test with a new cassette.

Professional-use notice: The supplied package insert identifies this configuration for healthcare professionals, including professionals at point-of-care sites. Do not describe the stocked professional product as an OTC or at-home self-test unless its current packaging and labeling specifically support that use.

Quality Control

A colored control line is the test’s internal procedural control. It helps confirm adequate sample volume, membrane wicking and correct technique. The package insert also recommends external positive and negative controls with each newly opened kit, new lot or shipment, after a change in operator, weekly as a check on storage conditions and as otherwise required by the laboratory’s quality system.

Storage and Handling

Store sealedStore the device in its sealed pouch at 36–86°F (2–30°C).

Do not freezeKeep the device protected in its pouch until ready for use.

Check expirationDo not use the test after the expiration date printed on the sealed pouch.

Single use onlyHandle urine samples as potentially hazardous and dispose of used devices according to applicable requirements.

Instructions and Regulatory Documents

Frequently Asked Questions

What does the ACCUTEST DS56A screen for?

It screens human urine for amphetamine, cocaine metabolite, marijuana metabolite, methamphetamine, opiates and phencyclidine at the cutoff concentrations listed above.

Is the DS56A CLIA waived?

Yes. The supplied DOA-1165 professional package insert identifies the test as CLIA waived.

Is this an over-the-counter home test?

The stocked configuration’s package insert is labeled for healthcare professionals, including professionals at point-of-care sites. It should not be presented as an OTC or home self-test without matching current OTC labeling and packaging.

Does this panel use an OPI 300 or OPI 2000 cutoff?

The linked package insert specifies OPI 2000, using morphine as the calibrator at a 2,000 ng/mL cutoff. The older 300 ng/mL value should not be used for this configuration.

How quickly are results available?

Read the test at 5 minutes. The package insert states that results may be read for up to 4 hours after test initiation.

What specimen is required?

This cassette is designed for human urine collected in a clean, dry container. Follow the supplied insert for sample storage and preparation requirements.

What does a faint test line mean?

When the control line is present, any visible test line is interpreted as negative regardless of the test line’s color intensity.

Does a preliminary positive result require confirmation?

Yes. A preliminary positive screening result must be confirmed using a more specific analytical method. The package insert identifies GC/MS as the preferred confirmatory method.

How many tests are included?

Each box contains 25 single-use test cassettes with disposable droppers and a package insert.

How should the test be stored?

Store the sealed device at 36–86°F (2–30°C). Do not freeze, and do not use the test after the expiration date printed on the pouch.

Additional information

Weight 1 lbs
Dimensions 7 × 5 × 3 in

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