The Amphetamine/Methamphetamine assay is used for the qualitative analysis of amphetamine/methamphetamine in human urine with a cutoff of 1,000 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine/methamphetamine use or overdose.

The Amphetamine/Methamphetamine assay is calibrated with d-methamphetamine and will detect a variety of amphetamines and their metabolites.

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

Device Description

Amphetamine/Methamphetamine is an in vitro diagnostic assay for the qualitative analysis of amphetamine/methamphetamine in human urine. The assay is a homogeneous enzyme immunoassay with a 1,000 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity.

AI/ML Overview

The Abbott Laboratories Amphetamine/Methamphetamine assay is a qualitative in vitro diagnostic assay used for the detection of amphetamine/methamphetamine in human urine.

Here's an analysis of its acceptance criteria and the study that proves it meets them:

1. Acceptance Criteria and Reported Device Performance:

The primary acceptance criterion for this device is substantial equivalence to a legally marketed predicate device. The study explicitly states the goal of demonstrating similar performance characteristics.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Substantial Equivalence (Predicate Device)	Agreement with Emit® II Monoclonal Amphetamine/Methamphetamine assay (K920507)	100% agreement (concordance)	This is the primary claim for substantial equivalence.
Substantial Equivalence (Confirmatory Method)	Acceptable correlation with GC/MS	81% agreement (concordance)	While 100% was achieved against the predicate assay, the agreement with GC/MS is lower at 81%, indicating some discrepancies.
Qualitative Analysis Cutoff	1,000 ng/mL	1,000 ng/mL	The device operates at the specified cutoff.
Limit of Detection (Sensitivity)	Not explicitly stated as an acceptance criterion for comparison, but reported.	500 ng/mL	This indicates the lowest concentration the device can reliably detect.
Precision	Not explicitly stated as an acceptance criterion for comparison, but reported.	Total %CV: Verifier I (0.42%), Cutoff Calibrator (0.40%), Verifier II (0.39%), -25% Control of Cutoff Calibrator (0.44%), +25% Control of Cutoff Calibrator (0.41%)	Very low %CV values indicate high precision (reproducibility) of the assay.

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

Test Set Size: The document does not explicitly state the total number of clinical specimens used for the comparative performance studies. It mentions that "The clinical specimens tested ranged from 826 to 1,994 ng/mL," which suggests a range of concentrations rather than a sample size. However, given the context of concordance tables, it can be inferred that a set of clinical specimens was used to compare the new assay against the predicate and GC/MS. The number of samples for each comparison is not provided.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

Number of Experts: Not applicable, as the ground truth was established by either a predicate device or a confirmatory chemical method (GC/MS), not by human expert interpretation.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The comparisons were made directly to the predicate device's results and GC/MS results. There's no mention of a human adjudication process to resolve discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No, there is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is an in vitro diagnostic assay, meaning its performance is assessed against analytical methods rather than human reader interpretation. Therefore, quantifying improvement with AI vs. without AI assistance is not relevant in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Standalone Study: Yes, the performance characteristics described (concordance, precision, limit of detection) represent the standalone performance of the Amphetamine/Methamphetamine assay (algorithm only). It does not involve a human in the loop for interpretation of the assay's direct output. The subsequent step for a preliminary positive result is confirmation by GC/MS, rather than human interpretation of the initial assay result.

7. Type of Ground Truth Used:

Type of Ground Truth:
- Predicate Device Results: For the primary substantial equivalence claim, the results from the Emit® II Monoclonal Amphetamine/Methamphetamine assay (K920507) were used as a comparative ground truth.
- Confirmatory Method: For additional correlation, Gas Chromatography/Mass Spectrometry (GC/MS) was used as a superior analytical chemical method, considered the "preferred confirmatory method" and thus a more definitive ground truth.

8. Sample Size for the Training Set:

The document does not provide information on the sample size for a training set. As this is a traditional immunoassay, it likely does not involve machine learning or AI models that require explicit training sets in the same way. The assay's performance is driven by its biochemical reagents and protocol.

9. How the Ground Truth for the Training Set Was Established:

As there is no mention of a training set or a machine learning component, this information is not applicable. The assay's "training" would be through its development and optimization process in the lab, which is not detailed here.

Summary

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

MAR 1 3 2002

510(k) Summary

K012998

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive MS 8-21 Irving, Texas 75038

Contact Person Alicia Simpson Senior Regulatory Affairs Specialist Regulatory Affairs (972) 518-7864 Fax (972) 518-6533

Date of Preparation of this Summary:

Device Trade or Proprietary Name:

Device Common/Usual Name or Classification Name:

November 21, 2001 Amphetamine/Methamphetamine

Amphetamine/Methamphetamine

Classification Number/Class:

LAF/Class II

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is: K012998.

Test Description:

Amphetamine/Methamphetamine is an in vitro diagnostic assay for the qualitative analysis of amphetamine/methamphetamine in human urine. The assay is a homogeneous enzyme immunoassay with a 1,000 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyne activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity.

Substantial Equivalence:

The Amphetamine/Mothamphetamine assay is substantially equivalent to the Eimit® II Monoclonal Amphetarnine/Methamphetamine assay (K920507) on the SYVA®-30R Analyzer.

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

Both assays vield similar Performance Characteristics.

Similarities:

. Both assays are in vitro immunoassays.
Both assays can be used for the qualitative analysis of amphetamine/methamine. .
. Both assays yield similar results.
Both assays are based on the competition between drug in the specimen and drug labeled with the enzyme ♥ glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites.

Differences:

Amphetamine/Methamphetamine is a qualitative assay. Emit II is a qualitative and semiquantitative assay. .

Intended Use:

The Amphetamine/Mcthamphetamine assay is used for the qualitative analysis of amphetamine in human urine with a cutoff of 1,000 ng/mL. For use in clinical laboratories.

The Amphetamine/Methamphetamine assay is calibrated with d-methamphetamine and will delect a variety of amphetamines and their metabolites.

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® System. The

Amphetamine/Methamphetamine assay method comparison yielded acceptable correlation with the Emir II Monoclonal Amphetamine assay on the SYVA-30R Analyzer. The concordance table shows 100% agreement. The Amphetamine assay method comparison yielded acceptable correlation with GC/MS. The concordiance table shows 81% agreement with GC/MS. The clinical specimens tested ranged from 826 to 1,994 ng/trL. Precision studies were conducted using the Amphetamine assay. A within-run and total precision study was performed using five levels of control material. The total %CV for Verifier I is 0.42%, Cutoff Calibrator is 0.40%. Verifier II is 0.39%. - 25% Connol of Cutoff Calibrator is 0.44%, and + 25% Control of Cuty/T Calibrator is 0.41%. The Amphetamine assay cutoff is 1,000 ng/mL. The limit of detection (sensitivity) of the Amphetamine/Methamphetamine assay is 500 ng/mL.

These data demonstrate that the performance of the Amphetamine assay is substantially equivalent to the performance of the Emit II Monoclonal Amphetamine assay on the SYVA-30R Analyzer.

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

Conclusion:

The Amphetamine/Methamphetamine assay is substantially equivalent to the Emit II Monoclonal Amphetamine/Methamphetamine assay on the SYVA-30R Analyzer as demonstrated by results obtained in the studies.

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

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The overall design is simple and monochromatic.

MAR 1 3 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Alicia Simpson Senior Regulatory Affairs Specialist Abbott Laboratories 1920 Hurd Drive 8-21 Irving, TX 75038

K012998 ... Re:

Trade/Device Name: Amphetamine/Methamphetamine Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ Dated: November 26, 2001 Received: November 28, 2001

Dear Ms. Simpson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 -

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 1 additionally 809.10 for in vitro diagnostic devices), please contact 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 Putman

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}------------------------------------------------

510(k) Number (if known): K012998

Device Name: Amphetamine/Methamphetamine

Indications For Use:

The Amphetamine/Methamphetamine assay is calibrated with d-methamphetamine and will detect a variety of amphetamines and their metabolites.

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

Prescription Use_ (Per 21 CFR 801.109) Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number, 1012958

Regulation Number and Section

§ 862.3610 Methamphetamine test system.

(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).