The Emit® II Plus Barbiturate Assay is a drugs-of-abuse homogeneous enzyme immunoassay intended for use in the qualitative and semiquantitative analysis of barbiturates in the human urine. Emit® II assays are designed for use with a number of chemistry analyzers. The Emit® II Plus Barbiturate 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.

Device Description

The Emit® II Plus Barbiturate Assay is a drugs-of-abuse homogenous enzyme assay intended for use in the qualitative and semiquantitative analysis of barbiturates in human urine. The Emit® II Plus Barbiturate Assay has been found to be equivalent to the predicate device. Emit® II Barbiturate Assay, with regard to intended use, assay sample, and overall performance characteristics.

AI/ML Overview

The provided text describes the Emit® II Plus Barbiturate Assay, an in vitro diagnostic device. The study described focuses on demonstrating equivalence to a predicate device rather than outright performance against a broad "acceptance criteria" in the way a novel AI device might. However, we can extract the performance characteristics and implicitly defined acceptance criteria from the information given.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Comparative Analysis
Agreement at 200 ng/mL cutoff (negative/positive)	High agreement with predicate device	94% agreement with predicate method
Agreement at 300 ng/mL cutoff (negative/positive)	High agreement with predicate device	100% agreement with predicate method
Spiked Sample Recovery (Qualitative Mode)
Correct identification of spiked specimens < -25% of 200 ng/mL secobarbital as negative	100% correct identification	Correctly identified as negative
Correct identification of spiked specimens > +25% of 200 ng/mL secobarbital as positive	100% correct identification	Correctly identified as positive
Correct identification of spiked specimens < -25% of 300 ng/mL secobarbital as negative	100% correct identification	Correctly identified as negative
Correct identification of spiked specimens > +25% of 300 ng/mL secobarbital as positive	100% correct identification	Correctly identified as positive
Spiked Sample Recovery (Semiquantitative Mode)
Recovery within range of nominal concentrations for 200-800 ng/mL secobarbital	Acceptable recovery (e.g., within a certain percentage)	99%-114% of nominal concentrations
Precision (Qualitative Mode)	Acceptable within-run and total precision
Within-run %CV (controls and cutoff rates)	Low %CV	0.4 - 0.5%
Total %CV (controls and cutoff rates)	Low %CV	0.6 - 0.7%
Precision (Semiquantitative Mode)	Acceptable within-run and total precision
Within-run %CV (controls and cutoff concentrations)	Low %CV	1.0 - 3.8%
Total %CV (controls and cutoff rates)	Low %CV	1.9 - 4.2%
Sensitivity	Ability to distinguish from 0 ng/mL with confidence	Less than 20 ng/mL (at 95% confidence)

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

Sample Size for Test Set: The document does not explicitly state the numerical sample size for the comparative analysis or spiked sample recovery tests. It refers to "samples" and "specimens" without providing a count.
Data Provenance: The document implies that the studies were conducted by Syva Company - Dade Behring Inc. There is no information provided regarding the country of origin of the data or whether it was retrospective or prospective. Given the nature of in vitro diagnostic device studies for regulatory submission, it is typically prospective or involves well-defined banked samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable in the context of this device and study. The "ground truth" for a chemical assay like this is typically established by reference methods (e.g., the predicate device or GC/MS), not by human experts.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are common in image interpretation studies where human expert disagreement needs to be resolved. For an immunoassay, the "adjudication" would be a comparison to the reference method (predicate device or GC/MS), which is a direct measurement or established analytical result.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation (e.g., radiology AI). The Emit® II Plus Barbiturate Assay is an automated chemical assay.

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

Yes, this entire study describes the standalone performance of the assay. There is no "human-in-the-loop" component for interpretation; the device provides a direct analytical result.

7. The Type of Ground Truth Used

Comparative Analysis: The "ground truth" was the result obtained from the predicate device, the Emit® II Barbiturate Assay.
Spiked Sample Recovery: The "ground truth" was the known concentration of secobarbital spiked into negative human urine specimens.
Sensitivity: The "ground truth" was the known concentration of secobarbital from 0 ng/mL upwards.

8. The Sample Size for the Training Set

This information is not applicable. This is an immunoassay, not a machine learning or AI device that requires a training set. The assay's performance is based on its chemical reagents and detection system, developed through traditional chemical and biological engineering, not trained on data in the AI sense.

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

Not applicable, as there is no "training set" in the context of this immunoassay.

Summary

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JAN 2 7 2000

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Emit® Il Plus Barbiturate Assay

1. Manufacturer and Contact Information:

Manufacturer:	Syva Company - Dade Behring Inc.20400 Mariani Ave.Cupertino, CA 95014
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Paul Rogers Contact Information: Syva Company - Dade Behring Inc. 3403 Yerba Buena Road San Jose, CA 95161-9013 Tel: 408-239-2000

2. Device Classification Name:

The Clinical Chemistry and Clinical Toxicology Devices Panel has classified "BarbiturateTest System" as Class II.

3. Intended Use:

4. Device Description and Characteristics:

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

Comparative Analysis: The Syva Emit® II Plus Barbiturate Assay showed excellent correlation to the Emit® II Barbiturate Assay (predicate method). The comparative analysis to the predicate method resulted in 94% agreement at the 200 ng/mL cutoff and 100% agreement at the 300ng/mL cutoff in finding samples negative and positive.

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Syva Emit® II Plus Barbiturate Assay (cont.)

Spiked Sample Recovery: Analysis of spiked sample recovery by the qualitative mode of the Emit II Plus Barbiturate Assay correctly identified the spiked specimens containing equal to or less than (<) minus (-) 25% of the 200 ng/mL secobarbital as negative and the spiked specimens containing equal to or greater than (>) plus (+) 25% of 200 ng/mL secobarbital as positive. The Emit® II Plus Barbiturate Assay also correctly identified the spiked specimens containing equal to or less than (<) minus (-) 25% of the 300 ng/mL secobarbital as negative and the spiked specimens containing equal to or greater than (>) plus (+) 25% of 300 ng/mL secobarbital as positive.

The semiquantitative attribute was assessed by determining the accuracy of recovery for analyte-spiked samples by the Emit® II Plus Barbiturate Assay. Negative human urine specimens were spiked with concentrations of secobarbital at levels throughout the semiquantitative range of 200 to 800 ng/mL. For each known concentration, drug recovery was calculated using the average concentration obtained by the Emit II Plus Barbiturate Assay. Within this range, recovery was within 99%-114% of nominal concentrations of spiked analyte.

Precision: A precision study was performed using Syva Emit® II Plus Barbiturate Assay in both the qualitative and semiguantitative modes. Acceptable within-run and total precision statistics for both the qualitative and semiquantitative modes of the assays were observed.

In the qualitative mode of the Emit® II Barbiturate Assay, the results demonstrated within-run precision with coefficients of variation (%CV) for controls and cutoff (rates) ranging from 0.4 - 0.5% and total precision with coefficients of variation (%CV) for controls and cutoff (rates) ranging from 0.6 - 0.7%.

In the semiquantitative mode of the assay the results demonstrated within-run precision with coefficients of variation (%CV) for controls and cutoff (concentrations) ranging from 1.0 - 3.8% and total precision with coefficients of variation (%CV) for controls and cutoff (rates) ranging from 1.9-4.2%.

Sensitivity: The sensitivity level of the Emit® II Plus Barbiturate Assay is less than 20 ng/mL. This level represents the lowest concentration of secobarbital that can be distinguished from 0 ng/mL with a confidence level of 95%.

5. Substantial Equivalence:

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three stripes forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

JAN 2 7 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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: K993987

Trade Name: Syva Emit® II Plus Barbiturate Assay Regulatory Class: II Product Code: KLT 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 OS 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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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

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Device Name: Syva Emit® II Plus Barbiturate Assay

Indications for Use:

Lean Cooge

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number +<993987

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription UseUse(Per 21 CFR 801.109)	OR	Over-The-Counter(Optional Format 1-2-96)
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Regulation Number and Section

§ 862.3645 Neuroleptic drugs radioreceptor assay test system.

(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.