The Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff (SAMSHA initial test cutoff level). The assay is intended for use in the qualitative and semi-quantitative analyses of benzoylecgonine (cocaine metabolite) in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

The Emit® II Plus Monoclonal Cocaine Metabolite Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-ofabuse test result, particularly when preliminary positive results are used.

Device Description

Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay for qualitative and semi-quantitative analysis of cocaine metabolite (benzoylecgonine) in human urine.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Syva Company - Dade Behring Inc. Emit® II Plus Cocaine Metabolite Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (150 ng/mL Cutoff)	Reported Device Performance (300 ng/mL Cutoff)
High agreement with GC/MS (reference method) for qualitative results	93% agreement with GC/MS	94% agreement with GC/MS

Note: The document does not explicitly state numerical acceptance criteria, but demonstrates a high percentage agreement with the Gas Chromatography/Mass Spectrometry (GC/MS) method, implying that high concordance is the de facto acceptance criterion.

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

150 ng/mL Cutoff: The number of samples is not explicitly stated, but the provided table shows:
- 2 samples testing positive by GC/MS (123 and 140 ng/mL) but negative by the device.
- 7 samples testing positive by GC/MS (150, 151, 157, 162, 164, 166, and 190 ng/mL) and positive by the device.
- The total number of samples where an agreement or disagreement is reported (excluding the header rows) is 9. However, the full sample size for the agreement percentage calculation is not provided.
300 ng/mL Cutoff: The number of samples is not explicitly stated, but the provided table shows:
- 6 samples testing positive by GC/MS (218, 241, 261, 294, 295, and 298 ng/mL) but negative by the device.
- 1 sample testing positive by GC/MS (354 ng/mL) and positive by the device.
- Similar to the 150 ng/mL cutoff, the full sample size for the agreement percentage calculation is not provided, only the cases of disagreement and agreement mentioned.
Data Provenance: Not specified (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

Not applicable for this type of device. The ground truth is established by a reference chemical/analytical method (GC/MS), not by human experts.

4. Adjudication Method for the Test Set

Not applicable as the ground truth is established by a single, definitive chemical method (GC/MS), not by human interpretation or consensus that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in-vitro diagnostic (IVD) device for chemical analysis, not an AI-powered diagnostic imaging or interpretation device that would involve human readers.

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

Yes, this is a standalone device. The device's performance is measured directly against the GC/MS reference method. It performs the analysis of benzoylecgonine in human urine without human interpretation affecting the direct assay output. The text states: "The Emit® II Plus Monoclonal Cocaine Metabolite Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method." This indicates the Emit® II Plus provides its own result which is then compared, and if positive, needs GC/MS for confirmation.

7. The Type of Ground Truth Used

Reference standard/Gold Standard: Gas Chromatography/Mass Spectrometry (GC/MS) is specified as the "preferred confirmatory method" and the method against which the Emit® II Plus assay results are compared.

8. The Sample Size for the Training Set

The document does not provide any information about a training set size. This assay is a homogeneous enzyme immunoassay, not a machine learning model that typically requires a distinct training set. The "method comparison" describes validation, not necessarily model training.

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

Not applicable, as no training set for a machine learning model is mentioned or implied.

Summary

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Syva Company - Dade Behring Inc. 510(K) Notification - K031512 Additional Information

JUL 2 8 2003

510(k) Summary for Emit® Il Plus Cocaine Metabolite Assay

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.

KO31512 The assigned 510(k) number is:

1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
  Manufacturer:

Contact Information:

Syva Company - Dade Behring Inc. 20400 Mariani Ave Cupertino, CA 95014

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497

Preparation date:

July 14, 2003

1. Device Name/ Classification:
  Emit® Il Plus Cocaine Metabolite Assay:

Cocaine and cocaine metabolite test system Class II (862.3250)

Product Code:

1. Identification of the Legally Marketed Device:
  Emit® II Plus Cocaine Metabolite Assay (K993988)

র্ব . Device Description:

Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay for qualitative and semi-quantitative analysis of cocaine metabolite (benzoylecgonine) in human urine.

91 DIO

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Syva Company - Dade Behring Inc. 510(k) Notification - K031512 Additional Information

ર. Device Intended Use:

The Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff (SAMSHA initial test cutoff level). The assay is intended for use in the qualitative and semi-quantitative analyses of benzoylecgonine (cocaine metabolite) in hurnan urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

The Emit® II Plus Monoclonal Cocaine Metabolite Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Medical device to which equivalence is claimed and comparison information: 6. The modified Emit® II Plus Cocaine Metabolite Assay is substantially equivalent in intended use to the Emil® II Plus Metabolite Assay currently marketed. The modified Emit® II Plus Metabolite Assay, like the current Emit® II Cocaine Metabolite Assay is intended to be used for the qualitative and semi-quantitative analyses of cocaine metabolite (benzoylecgonine) in human urine.

Device Performance Characteristics: 7.

Method Comparison:

Qualitative Results

150 ng/mL CUTOFF

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Percent agreement: 93%

· GC/MS results were 123 and 140 ng/mL

** GC/MS results were 150, 151, 157, 162, 164, 166, and 190 ng/mL

300 ng/mL CUTOFF

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Percent agreement: 94%

GC/MS results were 218, 241, 261, 294, 295, and 298 ng/mL

** GC/MS result was 354 ng/mL

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings, depicted in a stylized, minimalist design.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 3 2003

Ms. Kathleen Dray-Lyons Manager Regulatory Affairs and Compliance Syva Co., Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, DE 19714

Re: K031512

Trade/Device Name: Emit® II Plus Cocaine Metabolite Assay Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and Cocaine Metabolite test system Regulatory Class: Class II Product Code: DIO Dated: May 12, 2003 Received: May 14, 2003

Dear Ms. Dray-Lyons:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Syva Company - Dade Behring Inc. 510(k) Notification - K031512 Additional Information

Indications Statement

Emit® II Plus Cocaine Metabolite Assay Device Name:

Indications for Use:

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K031512

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

0000002

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

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