The Benzodiazepines assay is used for the qualitative analysis of benzodiazepines in human urine with a cutoff of 200 ng/mL. For use in clinical laboratories. Measurements obtained by this device are used in the diagnosis of benzodiazepines use or overdose. The Benzodiazepines assay is calibrated with lormetazepam and will detect a variety of benzodiazepines and their metabolites. The Benzodiazepines 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 (GCMS) 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

The Benzodiazepines assay is an in vitro diagnostic assay for the qualitative analysis of benzodiazepines in human urine. The assay is a homogeneous enzyme immunoassay with a 200 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 can be measured in terms of enzyme activity. Active enzyme concentration in the specimen can be measured in decreases upon binding to the antibody, so the drug converted D to NADH, resulting in an absorbance change that can be measured spectrophotometrically.

AI/ML Overview

This document describes the Abbott Laboratories Benzodiazepines assay, an in vitro diagnostic assay for the qualitative analysis of benzodiazepines in human urine. The summary provides information on its substantial equivalence to a predicate device and performance characteristics.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Agreement with predicate device (Emit II Benzodiazepine assay)	99% agreement
Agreement with GC/MS (reference method)	87% agreement
Sensitivity (Limit of Detection)	15 ng/mL
Precision (Within-run %CV)	Verifier I: 1.36%
	Cutoff Calibrator: 1.48% (total %CV)
	Verifier II: 1.10%
	-25% Control of Cutoff Calibrator: 1.92%
	+25% Control of Cutoff Calibrator: 1.60%
Cutoff	200 ng/mL

Study Details

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not explicitly state the total number of clinical specimens used in the comparative performance studies. However, it mentions that the clinical specimens tested ranged from 57.5 to 13,174.0 ng/mL, suggesting a variety of concentrations were included.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable for this type of in vitro diagnostic device study. The ground truth (or reference method) was established using another immunoassay (Emit II Benzodiazepine assay) and Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical chemical method and does not typically involve human expert interpretation for establishing ground truth in this context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable as the ground truth was established by analytical methods (another immunoassay and GC/MS) rather than human adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers interpreting results.

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

Yes, the performance characteristics describe the standalone performance of the Abbott Benzodiazepines assay. The "99% agreement" with the predicate device and "87% agreement" with GC/MS reflect the algorithm's performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth was established by:
- Predicate Device: Emit II Benzodiazepine assay on the SYVA-30R Analyzer (for "substantial equivalence" comparison).
- Reference Method: Gas Chromatography/Mass Spectrometry (GC/MS) (for analytical correlation).

8. The sample size for the training set:

The document does not provide information on a specific "training set" as this is not a machine learning or AI algorithm in the contemporary sense requiring a distinct training phase. This is an immunoassay, and its development would typically involve optimization and validation rather than training on a separate dataset in the way an AI model is trained.

9. How the ground truth for the training set was established:

Not applicable (see point 8).

Summary

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

MAR 1 3 2002

<013143

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive MS 1-8 Irving, Texas 75038

Regulatory Specialist Affairs Regulatory Affairs

November 21, 2001 Date of Preparation of this Summary Device Trade or Proprietary Name: Benzodiazepines Device Common/Usual Name or Class me: Benzodiazepines Classification Number/Class: JXM/Class II

This summary of 510(k) safety and effectivene formation is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.

The assigned 510(k) number is: K01314

Test Description:

The Benzodiazepines assay is an in vitro diagnostic assay for the qualitative analysis of benzodiazepines in human urinc. The assay is a homogeneous enzyme immunoassay with a 200 ng/mL cutoff. The assay is based on competition between arug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity concentration in the specimen can be measured in decreases upon binding to the antibody, so the drug terms of enzyme activity. Active enzyme conve D to NADH, resulting in an absorbance change that can be measured spectrophotometric

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

Substantial Equivalence:

The Benzodiazepines assay is substanti ent to the Emit II Benzodiazepine assay (K910376) on the SYVA-30R Analyzer.

Both assays yield similar Performance (

Similarities:

. Both assays are in vitro immunoass
י Both assays can be used for the qualitative at alysis of Benzodiazepines.
- Both assays yield similar results.
en drug in the specimen and drug labeled with the Both assays are based on the competitio . enzyme glucose-6-phosphate dehydrogenase G6PDH) for antibody binding sites.

Differences:

There is a difference between the as .
is a qualitative and semiquantitative assay. . Benzodiazepines is a qualitative assa

Intended Use:

ve analysis of benzodiazepines in human urine with The Benzodiazepines assay is used for the qualita a cutoff of 200 ng/mL. For use in clinical labora

The Benzodiazepines assay is calibrated w zepam and will detect a variety of benzodiazepines and their metabolites.

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® System. The Benzodiazepines assay method comparison yielded acceptable correlation with the Emit II Benzodiazepine assay on the SYVA-30R Analyzer. The concordance table shows: 99% agreement. The Benzodiazepines ussay method comparison yielded acceptable correlation with GC/MS. The concordance table shows 87% agreement with GCMS. The clinical specimens tested ranged from 57.5 to 13,174.0 ng/mL. Precision studies were conducted using the Benzodiazepin say. A within-run and total precision study was

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

%CV for Verifier I is 1.36%, The total %CV for the performed using five levels of material. The tota Cutoff Calibrator is 1.48%. The total %CV for Verifier II is 1.10%. The total %CV for the - 25% Control of Cutoff Calibrator and the +25% Control of Cutoff Calibrator samples are 1.92% and 1.60% respectively. The Benzodiazepines cutoff is 200 ng mL. The limit of detection (sensitivity) of the Benzodiazepines assay is 15 ng/mL. These data demonstrate that the performance of the Benzodiazepines assay is substantially equivalent to the performance of the Emit II Benzodiazepines assay on the SYVA-30R Analyzer.

Conclusion:

The Benzodiazepines assay is substantially equivalent to the Emit II Benzodiazepine 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 3 2002

Ms. Linda Morris Senior Regulatory Affairs Specialist Abbott Laboratories 1921 Hurd Dr. Irving. Texas 75038

Re: K013143

Trade/Device Name: Benzodiazephines Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiaphines test system Regulatory Class: Class II Product Code: JXM Dated: November 26, 2001 Received: November 28, 2001

Dear Ms. Morris:

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 I nits lotter will and the program al equivalence of your device to a legally marketed prealicate 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, (1) see 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Gutman

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): K013143

Benzodiazepine Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

gualitative analysis of benzodiazepines in human The Benzodiazepines assay is t in clinical laboratories. Measurements obtained by this urine with a cutoff of 200 ng/m1 for use ent of benzodiazepines use or overdose. device are used in the diagnosis at

with lormetazepam and will detect a variety of The Benzodiazepines assay is calibrated benzodiazepines and their metabolites

The Benzodiazepines 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 (GCMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive s are used.

a) Laboratory Devices

ONTINUE ON ANOTHER PAGE IF NEEDED) (PLEASE DO NOT WRITE BELOW TI

Prescription Use (Per 21 CFR 801.109)

of Device Evaluation (ODE) Concurrence of C

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.3170 Benzodiazepine test system.

(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).