'Rapid Drug Screen' 9-Panel is a one-step, lateral flow immunoassay for the simultaneous detection of 8 abused substances and tricyclic antidepressants in urine. The "Rapid Drug Screen" 9-Panel test is intended for use in the qualitative detection of the following 9 drugs in human urine at the following levels:

d-Amphetamine 750 ng/ml
Barbiturates 300 ng/ml
Benzodiazepines 300 ng/ml
Benzoyl ecognine 225 ng/ml
Cannabinoids (11-nor-9-carboxy-delta-9-THC) 50 ng/ml
Methamphetamine 1000 ng/ml
Opiates (codeine) 225 ng/ml
(morphine-3-glucuronide) 225 ng/ml
Phencyclidine (PCP) 19 ng/ml
Tricyclic Antidepressants 1000 ng/ml

'Rapid Drug Screen' 9-Panel is intended for use by professional laboratories. The assay to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS).

'Rapid Drug Screen' 9-Panel provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should-be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Description

All of the assays employed in the Rapid Drug Screen 9-Panel are based on the same principle of the highly specific reaction between antigens and antibodies.

Each assay is a one-step, immunoassay in which a specially-labeled drug (drug conjugate) competes with drug which may be present in the sample for the limited number of binding sites on an antibody. The test device consists of a membrane strip onto which a drug conjugate has been immobilized. A colloidal gold-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. An antibody-antigen reaction occurs forming a visible line in the 'test' area. The formation of a visible line in the test area occurs when the test is negative.

When drug is present in the urine sample, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If sufficient amount of drug is present, it will fill all of the available binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the test area is indicative of a positive result.

A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence of absence of drug in the urine, and therefore, should be present in all reactions.

A negative urine will produce two colored bands, and a positive sample will produce only one band.

AI/ML Overview

Here's an analysis of the provided text regarding the 'Rapid Drug Screen' 9-Panel, structured according to your requested information.

Acceptance Criteria and Device Performance Study for K992033: 'Rapid Drug Screen' 9-Panel

1. Table of Acceptance Criteria and Reported Device Performance

The device is a qualitative screening method; therefore, the primary performance criteria are sensitivity (correctly identifying positive samples) and specificity (correctly identifying negative samples) relative to a reference method at specific cut-off concentrations. The document defines the target cut-off levels for each drug as its acceptance criteria.

Drug / Analyte	Acceptance Criteria (Cut-off level)	Reported Device Performance (as tested against predicate/EMIT-II)
d-Amphetamine	750 ng/ml	Correctly identified positive and negative samples at/around these levels.
Barbiturates	300 ng/ml	Correctly identified positive and negative samples at/around these levels.
Benzodiazepines	300 ng/ml	Correctly identified positive and negative samples at/around these levels.
Benzoyl ecognine	225 ng/ml	Correctly identified positive and negative samples at/around these levels.
Cannabinoids (11-nor-9-carboxy-delta-9-THC)	50 ng/ml	Correctly identified positive and negative samples at/around these levels.
Methamphetamine	1000 ng/ml	Correctly identified positive and negative samples at/around these levels.
Opiates (codeine)	225 ng/ml	Correctly identified positive and negative samples at/around these levels.
Opiates (morphine-3-glucuronide)	225 ng/ml	Correctly identified positive and negative samples at/around these levels.
Phencyclidine (PCP)	19 ng/ml	Correctly identified positive and negative samples at/around these levels.
Tricyclic antidepressants	1000 ng/ml	Correctly identified positive and negative samples at/around these levels.

Summary of Performance Study:
The study compared the 'Rapid Drug Screen' 9-Panel to two predicate devices: American BioMedica 'Rapid Drug Screen' 9-Panel test kit (K983770) and Biosite Diagnostics' Triage® Panel for Drugs of Abuse plus Tricyclic Antidepressants (K955935), and to Syva EMIT-II for initial positive identification.

Positive Agreement: The device "correctly identified all of the… 40 drug-containing specimens to be positive" when compared to Syva EMIT-II.
Negative Agreement: The device "correctly identified all of the… fifty (50) of which were found to be drug-free" when compared to predicate devices/Syva EMIT-II.
Reproducibility: Evaluated using control urines containing concentrations above and below the stated cut-off, as well as negative controls. The results "confirmed the reproducibility of the Rapid Drug Screen 9-Panel performance."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Size: 90 samples.
- 50 drug-free samples.
- 40 drug-containing samples.
Data Provenance: Not explicitly stated (e.g., country of origin, demographics). The samples were "selected for evaluation," implying they were pre-collected. The study is retrospective in the sense that existing samples (either drug-free or pre-identified as positive by EMIT-II) were used. It does not mention prospective collection or controlled spiking of samples to reach specific concentrations for evaluation against the cut-offs, though reproducibility was checked with control urines "above and below the stated cut-off."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in the typical sense for this type of IVD device. The ground truth for the drug-containing samples relied on a laboratory method for detection, not expert human interpretation of images or other data.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by laboratory methods (Syva EMIT-II for initial screening of positives, HPLC for confirmation of identification but not quantification).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a point-of-care or laboratory screening immunoassay; human "readers" are not involved in interpreting complex data, but rather a simple visual presence or absence of a line. The comparison was device-to-device and device-to-laboratory method, not reader-to-reader.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, this is a standalone device study. The device itself (the immunoassay) provides the result based on chemical reactions. A human merely reads the visual output (presence or absence of a line). The study evaluates the performance of the device itself.

7. The Type of Ground Truth Used

The ground truth was established using established laboratory methods:

Initial screening for positive samples: Syva EMIT-II.
Confirmation for positive samples: HPLC (identified but not quantified).
For reproducibility: "Control urines containing concentrations above and below the stated cut-off" and "Negative controls."

8. The Sample Size for the Training Set

Not applicable. This device is an immunoassay, not a machine learning algorithm that requires a training set. Its performance is based on the chemical specificity and sensitivity of the antigen-antibody reactions embedded in its design.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an immunoassay.

Summary

{0}------------------------------------------------

K992033

Attachment D

510(k) Summary

Submitter's Name/Address: American BioMedica Corporation

300 Fairview Avenue Hudson, NY 12534

Contact Person: Henry J. Wells, Ph.D. Vice President of Product Development Phone: (410) 992-9357 Fax: (410) 992-0328

June 1999 Date of Preparation of this Summary:

Device Trade or Proprietary Name:

'Rapid Drug Screen' 9-Panel

Device Common/Usual Name or Classification Name: Rapid Drug Screen 9-Panel

Classification Number/Class:

[no classification number]/Class II

This 510(k) Summary is being submitted in accordance with the requirements of 21 C.F.R. § 807.92.

The assigned 510(k) is:

Predicate Devices: American BioMedica 'Rapid Drug Screen' 9-Panel test kit (510(k) No. K983770) and Biosite Diagnostics' Triage® Panel for Drugs of Abuse plus Tricyclic Antidepressants (510(k) No. K955935).

Test Description:

All of the assays employed in the Rapid Drug Screen 9-Panel are based on the same principle of the highly specific reaction between antigens and antibodies.

{1}------------------------------------------------

A negative urine will produce two colored bands, and a positive sample will produce only one band.

Intended Use:

The Rapid Drug Screen 9-Panel test is used for the qualitative detection of damphetamine; barbiturates; benzodiazepines; benzol ecognine; cannabinoids; dmethamphetamine; opiates; phencyclidine (PCP); and tricyclic antidepressants in human urine. This immunoassay is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing. i.e. gas-chromatography/mass spectrometry (GC/MS).

Performance Characteristics:

'Rapid Drug Screen' 9-Panel will detect 9 drugs in human urine at the following levels:

d-Amphetamine	750 ng/ml
Barbiturates	300 ng/ml
Benzodiazepines	300 ng/ml
Benzoyl ecognine	225 ng/ml
Cannabinoids
(11-nor-9-carboxy-delta-9-THC)	50 ng/ml
Methamphetamine	1000 ng/ml
Opiates (codeine)	225 ng/ml
(morphine-3-glucuronide)	225 ng/ml
Phencyclidine (PCP)	19 ng/ml
Tricyclic antidepressants	1000 ng/ml

'Rapid Drug Screen' 9-Panel was compared to the previously 510(k) cleared 'Drug Screen' 9-Panel (510(k) No. K983770) and Biosite Triage Plus TCA tests. Ninety (90) samples were selected for evaluation, fifty (50) of which were found to be drug-free and forty (40) tested as positive by Syva EMIT-II. The forty positive specimens were identified but not quantified by HPLC. Both immunoassays correctly identified all of the

{2}------------------------------------------------

specimens which contained no drug as negative and determined the 40 drug-containing specimens to be positive.

Reproducibility was evaluated using control urines containing concentrations above and below the stated cut-off. Negative controls were also used. The results confirmed the reproducibility of the Rapid Drug Screen 9-Panel performance.

Conclusion:

The Rapid Drug Screen 9-Panel test is substantially equivalent to the previously-cleared 'Rapid Drug Screen' 9-Panel test (510(k) No. K983770) and the Triage® Panel for Drugs of Abuse plus Tricyclic Antidepressants (510(k) No. K955935), as demonstrated by results obtained in the studies.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 30 1999

American Bio Medica c/o Mr. John B. Dubeck, Esq. Keller and Heckman LLP 1001 G Street NW, Suite 500W Washington, DC 20001

K992033 Re:

Trade Name: 'Rapid Drug Screen' 9-Panel Regulatory Class: II Product Code: DKZ, DIS, JXM, DJG, DIO, LDJ, LAF, LCL, LFG Dated: June 16, 1999 Received: June 16, 1999

Dear Mr. Dubeck:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please wontact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page _ of _

510(k) Number (if known):	K992033
---------------------------	---------

"Rapid Drug Screen" 9-Panel Device Name:

Indications For Use:

d-Amphetamine	750 ng/ml
Barbiturates	300 ng/ml
Benzodiazepines	300 ng/ml
Benzoyl ecognine	225 ng/ml
Cannabinoids
(11-nor-9-carboxy-delta-9-THC)	50 ng/ml
Methamphetamine	1000 ng/ml
Opiates (codeine)	225 ng/ml
(morphine-3-glucuronide)	225 ng/ml
Phencyclidine (PCP)	19 ng/ml
Tricyclic Antidepressants	1000 ng/ml

'Rapid Drug Screen' 9-Panel is intended for use by professional laboratories. The assay to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a ‫(1 at provides only a ‫(1 determining the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS).

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

tan Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _ 人 01720

Prescription Use
(Per 21 CFR 801.109)

4 1.

Over-The-Counter Use

(Octional Format 1 2-06)

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).