K Number
K993988
Device Name
SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
Manufacturer
Date Cleared
2000-01-27

(64 days)

Product Code
Regulation Number
862.3250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Emit® II Plus Cocaine Metabolite Assay is a homogeneous drugs-of-abuse 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 semiquantitative 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 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 judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Device Description
The Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecognine (cocaine metabolite) in human urine. The Emit® II Plus Cocaine Metabolite Assay and has been found to be equivalent to the predicate device: Emit® II Cocaine Metabolite Assay with regard to intended use, assay sample, and overall performance characteristics.
More Information

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No
The summary describes a standard enzyme immunoassay for drug detection, which relies on chemical reactions and optical measurements, not AI/ML algorithms for analysis or interpretation. There is no mention of AI, ML, or related concepts in the document.

No
This device is an in vitro diagnostic assay used for the qualitative and semiquantitative analysis of cocaine metabolite in human urine, which provides preliminary analytical test results and is not used for treatment.

Yes
The device is described as an "enzyme immunoassay" intended for "qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine" to produce a "preliminary analytical test result," which are all characteristics of a diagnostic device.

No

The device is a homogeneous enzyme immunoassay, which is a chemical reagent-based test, not a software-only device. It is intended for use with chemistry analyzers, which are hardware.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states the assay is for the "qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide information about a person's health status (presence of a drug metabolite).
  • Sample Type: The device analyzes "human urine," which is a biological specimen.
  • Method: It uses an "enzyme immunoassay," which is a common technique used in IVD tests to detect specific substances in biological samples.
  • Purpose: The purpose is to detect the presence of a drug metabolite, which is a diagnostic or screening function.

The description clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.

N/A

Intended Use / Indications for Use

The Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiguantitative analyses of benzoylecognine (cocaine metabolite) in human urine. The Emit® II Plus 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 judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Product codes

DIO

Device Description

The Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecognine (cocaine metabolite) in human urine. The Emit® II Plus Cocaine Metabolite Assay and has been found to be equivalent to the predicate device: Emit® II Cocaine Metabolite Assay with regard to intended use, assay sample, and overall performance characteristics.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

Comparative Analysis:
The Emit® II Plus Cocaine Metabolite Assay showed excellent correlation to GC/MS (reference method) for the optional 150 ng/mL cutoff level. The GC/MS reference method has a limit of quantitation (LOQ) of 30 ng/mL. The percent agreement between these methods was 100%. The Emit® II Plus Cocaine Metabolite Assay showed excellent correlation between Emit® II Cocaine Metabolite Assay and The Emit® II Cocaine Metabolite Assay (comparative method) at the 300 ng/mL cutoff level. The percent agreement between these methods was 98%. Three samples were discordant and were analyzed by GC/MS. These samples were borderline positive with the Emit® II Plus 300 ng/mL Cocaine Metabolite Assay. These borderline results were with-in the precision limit of the Emit® II Cocaine Metabolite Assay (comparative method).

All positive samples and a portion of negative samples (n=20), as assessed by the Emit® 11 Plus Cocaine Assay, were analyzed by GC/MS for confirmatory (positive samples) and specificity (negative samples) purposes.

Spiked Sample Recovery:
The qualitative and semiquantitative attributes were assessed by determining the accuracy for the analyte in spiked samples by the Emit® II Plus Cocaine Metabolite Assay.

Qualitative -150 ng/mL cutoff
Known levels of benzovlecognine, spiked at levels less than or equal to the minus 25% of the 150 ng/mL cutoff (0-112.5 ng/mL) were distinguished as negative. Spiked levels greater than or equal to plus 25% for the 150 no/mL cutoff (187 – 3000 na/mL) were routinely distinguished positive.

Qualitative - 300 nq/mL cutoff
Known levels of benzoylecognine, spiked at levels less than or equal to minus 25% of the 300 ng/mL cutoff (0-225 ng/mL) were distinauished as negative. Spiked levels greater than or equal to plus 25% of the 300 ng//mL cutoff (375- 3000 ng/mL) were routinely distinguished positive.

The semiquantitative results for known spiked concentrations for the Emit® II Plus 150/300 ng/mL Cocaine Metabolite assay recovered with-in 20% of the nominal value between 45 ng/mL and 900 ng/mL.

Precision:
A precision study was performed on the two cutoff levels (150/300ng/mL) using the Emit® II Plus Cocaine Metabolite Assay in both the qualitative and semiquantitative modes. Acceptable with-in run and total precision statistics in both the qualitative and the semiquantitative assays were observed.

In the qualitative mode the with-in run precision demonstrated coefficients of variation (%CV) for controls and cutoffs (rates) ranged from 0.4 to 0.5% and the total precision with %CV's for controls and cutoff (rates) ranged from 0.5 to 0.6%.

In the semiquantitative mode the with-in run precision demonstrated coefficient of variation (%CV) for controls and cutoffs (concentrations) ranged from 3.7 to 10.9 % and the total precision %CV's for controls and cutoff (concentrations) ranged from 5.1 to 14.9%.

Key Metrics

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Predicate Device(s)

Emit® II Cocaine Metabolite Assay

Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 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).

0

JAN 2 7 2000

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. Manufacturer and Contact Information:

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

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Contact Information: Paul Rogers Syva Company- Dade Behring Inc. 3403 Yerba Buena Road San Jose, CA 95161-9013 Tel: 408-239-2309

2. Device Classification Name:

"Cocaine metabolite test system" has been classified as Class II Reference: 21 CRF8862.3250. revised April 1, 1998

3. Intended Use:

The Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiguantitative analyses of benzoylecognine (cocaine metabolite) in human urine. The Emit® II Plus 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 judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

4. Device Description and Characteristics:

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.

The Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecognine (cocaine metabolite) in human urine. The Emit® II Plus Cocaine Metabolite Assay and has been found to be equivalent to the predicate device: Emit® II Cocaine Metabolite Assay with regard to intended use, assay sample, and overall performance characteristics.

1

Comparative Analysis:

The Emit® II Plus Cocaine Metabolite Assay showed excellent correlation to GC/MS (reference method) for the optional 150 ng/mL cutoff level. The GC/MS reference method has a limit of quantitation (LOQ) of 30 ng/mL. The percent agreement between these methods was 100%. The Emit® II Plus Cocaine Metabolite Assay showed excellent correlation between Emit® II Cocaine Metabolite Assay and The Emit® II Cocaine Metabolite Assay (comparative method) at the 300 ng/mL cutoff level. The percent agreement between these methods was 98%. Three samples were discordant and were analyzed by GC/MS. These samples were borderline positive with the Emit® II Plus 300 ng/mL Cocaine Metabolite Assay. These borderline results were with-in the precision limit of the Emit® II Cocaine Metabolite Assay (comparative method).

All positive samples and a portion of negative samples (n=20), as assessed by the Emit® 11 Plus Cocaine Assay, were analyzed by GC/MS for confirmatory (positive samples) and specificity (negative samples) purposes.

Spiked Sample Recovery:

The qualitative and semiquantitative attributes were assessed by determining the accuracy for the analyte in spiked samples by the Emit® II Plus Cocaine Metabolite Assay.

Qualitative -150 ng/mL cutoff

Known levels of benzovlecognine, spiked at levels less than or equal to the minus 25% of the 150 ng/mL cutoff (0-112.5 ng/mL) were distinguished as negative. Spiked levels greater than or equal to plus 25% for the 150 no/mL cutoff (187 – 3000 na/mL) were routinely distinguished positive.

Qualitative - 300 nq/mL cutoff

Known levels of benzoylecognine, spiked at levels less than or equal to minus 25% of the 300 ng/mL cutoff (0-225 ng/mL) were distinauished as negative. Spiked levels greater than or equal to plus 25% of the 300 ng//mL cutoff (375- 3000 ng/mL) were routinely distinguished positive.

The semiquantitative results for known spiked concentrations for the Emit® II Plus 150/300 ng/mL Cocaine Metabolite assay recovered with-in 20% of the nominal value between 45 ng/mL and 900 ng/mL.

Precision:

A precision study was performed on the two cutoff levels (150/300ng/mL) using the Emit® II Plus Cocaine Metabolite Assay in both the qualitative and semiquantitative modes. Acceptable with-in run and total precision statistics in both the qualitative and the semiquantitative assays were observed.

In the qualitative mode the with-in run precision demonstrated coefficients of variation (%CV) for controls and cutoffs (rates) ranged from 0.4 to 0.5% and the total precision with %CV's for controls and cutoff (rates) ranged from 0.5 to 0.6%.

2

In the semiquantitative mode the with-in run precision demonstrated coefficient of variation (%CV) for controls and cutoffs (concentrations) ranged from 3.7 to 10.9 % and the total precision %CV's for controls and cutoff (concentrations) ranged from 5.1 to 14.9%.

5. Substantial Equivalence:

In conclusion, SYVA Company- Dade Behring Inc. considers the Emit® II Plus Cocaine Metabolite Assay to be substantially equivalent to the Emit® II Cocaine Metabolite Assay with regard to intended use, assay sample, and overall performance characteristics.

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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 7 2000

Mr. Paul L. Rogers, Jr. Senior Manager, Regulatory Affairs Syva Company - Dade Behring Inc. 3403 Yerba Buena Road P.O. Box 49013 San Jose, California 95161-9013

Re: K993988

Trade Name: Emit® II Plus Cocaine Metabolite Assay Regulatory Class: II Product Code: DIO Dated: November 24, 1999 Received: November 24, 1999

Dear Mr. Rogers:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation 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 yours,

Steven Autman

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

K 993988

Device Name: Emit® II Plus Cocaine Metabolite Assay

Indications for Use:

The Emit® II Plus Cocaine Metabolite Assay is a homogeneous drugs-of-abuse 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 semiquantitative 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 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 judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

coger

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 993988

(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) ✓

OR

over-the-counter Use

(Optional Format 1-2-96)

Device Name: Emit® II Plus Cocaine Metabolite Assay