The Emit® II Plus Monoclonal 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-of-abuse test result, particularly when preliminary positive results are used.

Device Description

Emit® II Plus Monoclonal 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 an analysis of the provided text, outlining the acceptance criteria and study details for the Emit® II Plus Monoclonal Cocaine Metabolite Assay:

Acceptance Criteria and Device Performance

The provided document describes a method comparison study to demonstrate substantial equivalence to a legally marketed predicate device (Emit® II Plus Cocaine Metabolite Assay). The primary acceptance criterion appears to be a high percentage agreement between the new device and the comparative method.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance (150 ng/mL Cutoff)	Reported Device Performance (300 ng/mL Cutoff)
High Percent Agreement with Comparative Method	96%	98%

Study Details

Here's a breakdown of the study that proves the device meets the acceptance criteria:

A table of acceptance criteria and the reported device performance:

See table above.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: 110 samples for both the 150 ng/mL cutoff and the 300 ng/mL cutoff analyses.
- Data Provenance: The document does not specify the country of origin. It also doesn't explicitly state whether the samples were collected retrospectively or prospectively. However, given it's a method comparison for a new assay, it's most likely that a set of existing or collected samples were used for retrospective analysis.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- The document does not specify the number of experts or their qualifications. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical chemical method, not human expert consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- There was no human "adjudication" in the traditional sense, as the ground truth was determined by GC/MS. The Emit® II Plus Monoclonal Cocaine Metabolite Assay results were compared against the Emit® II Plus Cocaine Metabolite Assay results, with GC/MS serving as the gold standard for confirmation, particularly for discrepancies.
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:
- No. This study is for an in-vitro diagnostic (IVD) immunoassay, not an AI-powered diagnostic imaging device or a system requiring human interpretation. Therefore, an MRMC study and human reader improvement due to AI assistance are not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this study represents a standalone performance evaluation of the Emit® II Plus Monoclonal Cocaine Metabolite Assay. The device is a homogeneous enzyme immunoassay, which provides a direct output result without human interpretive input for the primary analytical test. The results were then compared to a legally marketed predicate device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for confirmation was Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "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." For the samples identified as false negatives by the new assay, GC/MS results confirmed the presence of benzoylecgonine at specific concentrations.
The sample size for the training set:
- The document does not provide information about a separate "training set" or its size. This is common for conventional immunoassay development, where a "training set" in the machine learning sense is not typically used. The development of the assay itself would have involved laboratory optimization and characterization rather than a distinct training phase on a dataset of clinical samples.
How the ground truth for the training set was established:
- As no specific "training set" is mentioned in the context of this 510(k) submission for an immunoassay, the establishment of ground truth for such a set is not described. The assay's performance characteristics are established through analytical validation and method comparison using samples with known concentrations confirmed by a gold standard like GC/MS.

Summary

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Syva Company - Dade Behring Inc 510(k) Notification - K02044 Additional Information

MAR 2 8 2002

510(k) Summary for Emit® II Plus Monoclonal 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.

The assigned 510(k) number is: KO2O 44 |

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

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

Contact Information:

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:

March 26, 2002

2. Device Name/ Classification:

Emit® Il Plus Monoclonal Cocaine Metabolite Assay: Cocaine and cocaine metabolite test system Class II (862.3250)

91 DIO Product Code:

Identification of the Legally Marketed Device: 3.

Emit® II Plus Cocaine Metabolite Assay (K011162)

4. Device Description:

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

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Syva Company - Dade Behring Inc. 510(k) Notification - KD20441 Additional Information

Device Intended Use: 5.

Medical device to which equivalence is claimed and comparison information: હ. The modified Emil® II Plus Monoclonal Cocaine Metabolite Assay is substantially equivalent in intended use to the Emit® II Plus Cocaine Metabolite Assay currently marketed. The modified Emit® II Plus Monoclonal Cocaine 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.

7. Device Performance Characteristics:

Method Comparison:

Qualitative Results

150 ng/mL CUTOFF

One hundred and ten (110) samples were analyzed by the Emit® II Plus Monoclonal Cocaine Metabolite Assay and the Emit® II Plus Cocaine Metabolite Assay on the SYVA®-30R Biochemical System. Forty-six (46) samples showed positive results by both methods, and 60 samples showed negative results by both methods. Of the forty-six (46) specimens showing positive results by the Emite II Plus Monoclonal Cocaine Metabolite Assay, forty-two (42) were confirmed by GC/MS to contain cocaine metabolite between 150 ng/mL and greater than 1000 ng/mL benzoylecgonine. Data are summarized in the table below.

	Comparative Method
	+	-
+	46	0
-	4 *	60

Qualitative Results for the 150 ng/mL Cutoff

Shown to contain 25, 46, 99 and 110 ng/mL benzovlecgonine as determined by GC/MS.

Of the one hundred (110) method comparison samples, 19% were within ±25% of the cutoff value. Percent Agreement: 96%

000007

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Syva Company - Dade Behring Inc. 51 D(k) Notification - K020441 Additional Information

300 ng/mL CUTOFF

One hundred and ten (110) samples were analyzed by the Emit® II Plus Monoclonal Cocaine Metabolite Assay and the Emit II Plus Cocaine Metabolite Assay on the SYVA®-30R Blochemical System. Twenty-nine (29) samples showed positive results by both methods, and seventy-nine (79) samples showed negative results by both methods. both memods, and seventy-line (10) Samplos Showed Nogative Togation of Sun Monoclonal Cocaine Metabolite Assay, twenty-eight (28) were confirmed by GC/MS to contain cocaine metabolite between 300 ng/ml_ and greater than 1000 ng/mL benzoylecgonine. Data are summarized in the table below.

Qualitative Results for the 300 ng/mL Cutoff

	Comparative Method
	+	-
+	29	0
Emit® II PlusMonoclonalCocaine MetaboliteAssay	-	2 *	79

Shown to contain 218 and, 235 ng/mL benzoylecgonine as determined by GC/MS.

Of the one hundred (110) method comparison samples, 16% were within ±25% of the cutoff value.

Percent Agreement: 98%

0000008

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird with three stylized lines representing its wings or feathers.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 8 2002

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

Re: K020441

Trade/Device Name: Emit ® II Plus Monoclonal 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: February 8, 2002 Received: February 11, 2002

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 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.

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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 i 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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

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dditional Information

Indications Statement

Device Name:

Emit® II Plus Monoclonal Cocaine Metabolite Assay

Indications for Use:

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.

D.R.

Division of Clinical Laboratory Devices KO20441 510(k) Number __

(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)

0000004

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).