The Emit® II Plus Monoclonal Amphetamine Assay is a homogeneous enzyme immunoassay with a 1000 ng/ml cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semi-quantitative analysis of amphetamines in human urine. These reagents are packaged specifically for use on a variety of Olympus® analyzers.

The Emit® II Plus Monoclonal Amphetamine 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

The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.

AI/ML Overview

The provided text is a 510(k) summary for the Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay. It establishes the device's substantial equivalence to a predicate device and states its intended use. However, it does not include detailed acceptance criteria, a study demonstrating performance against those criteria, or the specific information requested in the prompt regarding sample sizes, ground truth establishment, or clinical study designs.

Therefore, most of the information requested cannot be extracted from this document. The document primarily focuses on regulatory approval based on equivalence rather than presenting a performance study with detailed acceptance criteria.

Here's what can be inferred or explicitly stated from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not define specific acceptance criteria (e.g., sensitivity, specificity thresholds) nor report detailed performance metrics against such criteria. It states that the "assay performance characteristics" are the same as the predicate device, implying that the predicate device's performance would be the reference, but no specific numbers are given.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not describe a new performance study with a test set. The submission is based on the device being substantially equivalent to a predicate device, with minor changes primarily related to packaging and compatibility with different analyzers.

3. 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)

Cannot be provided. No new test set is described, so no information on experts or ground truth establishment for such a set is present.

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

Cannot be provided. No new test set or adjudication method is described.

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

Cannot be provided. This device is an in-vitro diagnostic (IVD) assay for drug detection, not an AI-assisted diagnostic tool that would involve human readers interpreting results in a comparative effectiveness study.

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

Cannot be provided. While an IVD assay functions "standalone" without human interpretation in the sense of a clinical reader, the document does not present results of a standalone performance study with specific metrics. It relies on the substantial equivalence to an existing device.

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

Cannot be provided for a new study. For drug-of-abuse assays, the "ground truth" for confirming positive results typically involves more specific analytical methods like Gas Chromatography/Mass Spectrometry (GC/MS). The document mentions GC/MS as the preferred confirmatory method for preliminary positive results, implying how clinical ground truth would be established for patient samples, but not for a specific device validation study described in this document.

8. The sample size for the training set

Not applicable/Cannot be provided. This is an enzyme immunoassay, not a machine learning model. There is no concept of a "training set" in the context of this device.

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

Not applicable/Cannot be provided. As above, no training set.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence for a minor modification (packaging and analyzer compatibility) of an existing in-vitro diagnostic device. It does not describe or report the outcomes of a new performance study that would establish new acceptance criteria or detailed performance metrics.

Summary

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AUG - 3 2001

K012257

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay

1. Manufacturer and Contact Information:

Manufacturer:	Syva Company - Dade Behring Inc.20400 Mariani Ave.Cupertino. CA 95014
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Susan L. Collins Contact Information: Regulatory Affairs Syva Company - Dade Behring, Inc. 20400 Mariani Avenue Cupertino, CA 95014 Tel: 408 - 366-3840 Fax: 408 - 366-3725

1. Date Summary Prepared:
  July 17, 2001

3. Device Trade Name:

Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay

4. Common Name:

Enzyme Immunoassay, Methamphetamine Enzyme Immunoassay, Amphetamine

5. Device Classification Name:

The Clinical Chemistry and Clinical Toxicology Devices Panel have classified "Methamphetamine test system" as Class II, 21 CFR Part 862.3610, 91LAF and "Amphetamine test system" as Class II, 21 CFR 862.3100, 91DKZ.

6. Intended Use:

7. Device Description:

8. Substantial Equivalence

The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device. In conclusion the modified Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay is substantially equivalent to the predicate Emit® II Plus Monoclonal Amphetamine/Methampe Assay.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

AUG - 3 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Susan L. Collins Regulatory Affairs Syva Company-Dade Behring Inc. 20400 Mariani Avenue Cupertino, CA 95014

510(k) Number: K012257 Re: STO(K) Namocional Provis Monoclonal Amphetamine/Methamphetamine Assay Regulation Number: 862.3610, 862.3100 Regulatory Class: II Product Code: DKZ, LAF Dated: July 17, 2001 Received: July 18, 2001

Dear Ms. Collins:

We have reviewed your Section 510(k) notification of intent to market the device referenced wo have lovice four bothed the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, 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 1 court I ood, Drog, and consist of the Act. The general controls provisions of the Act include the general volusiness 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 (1 remancer repression) in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through r raction of inspections, the Food and Drug Administration (FDA) will verify such periodio Ship may regulation may regulation may result in regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, I DIA may pachase to your premarket notification submission does not affect reemer. Freason 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.

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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 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 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 vours.

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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Indications for Use Statement หัวเลวรา

510(k) Number (if known):

Device Name: Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay

Indications for Use:

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K612257

(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)

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).