The Barbiturate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semiquantitative analyses of barbiturates in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.

Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

The Barbiturate Enzyme Immunoassay 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. Clinical consideration and professional judgment should be applied to any drug-ofabuse test result, particularly when preliminary positive results are used.

The Barbiturate Drug of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine.

The Barbiturate Drug of Abuse Controls are intended for in vitro diagnostic use for the validation of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine.

Device Description

LZI's Barbiturate Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect barbiturates in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.

The assay is based on competition between barbiturate labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme and free drug from the urine sample for a fixed amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled G6PDH enzyme causing a decrease in enzyme activity. It is therefore the drug concentration is proportional to the enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.

All of the Single Analyte Urine DAU Calibrators and Controls are human urine-based liquid, and ready to use. These Calibrators and Controls do not have any especially unique technical characteristics. Each contains a known concentration of a specific drug analyte.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Lin-Zhi International, Inc. Barbiturate Enzyme Immunoassay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined acceptance criteria with specific thresholds for each performance metric. However, we can infer the acceptance criteria for the LZI device by comparing its performance to that of the predicate device (Syva EMIT® II Plus Barbiturate Assay). The goal is to show comparable or acceptable performance.

Feature	Predicate Device (SYVA's Barbiturate EIA) Reported Performance	LZI's Barbiturate EIA Reported Performance	Inferred Acceptance Criteria/Comparison
Precision
Within Run Qualitative (mAbs/min %CV)	Negative: 0.4%150 ng/mL: 0.4%200 ng/mL: 0.5%225 ng/mL: 0.4%250 ng/mL: 0.4%300 ng/mL: 0.5%375 ng/mL: 0.4%	Negative: 0.8%100 ng/mL: 0.6%200 ng/mL: 1.1%300 ng/mL: 0.1%400 ng/mL: 0.7%1000 ng/mL: 0.6%	Comparable %CV to predicate; generally low %CVs (e.g., <5%). LZI's values are mostly in the same low range.
Within Run Semi-quantitative (ng/mL %CV)	150 ng/mL: 3.8%200 ng/mL: 1.8%225 ng/mL: 1.5%250 ng/mL: 1.4%300 ng/mL: 1.3%375 ng/mL: 1.0%	100 ng/mL: 4.8%200 ng/mL: 3.8%300 ng/mL: 2.8%400 ng/mL: 3.6%	Comparable %CV to predicate; generally low %CVs (e.g., <5%). LZI's values are mostly in the same low range.
Run-To-Run Qualitative (mAbs/min %CV)	Negative: 0.6%150 ng/mL: 0.6%200 ng/mL: 0.6%225 ng/mL: 0.6%250 ng/mL: 0.6%300 ng/mL: 0.6%375 ng/mL: 0.7%	Negative: 0.8%100 ng/mL: 0.7%200 ng/mL: 0.5%300 ng/mL: 0.4%400 ng/mL: 0.4%1000 ng/mL: 0.4%	Comparable %CV to predicate; generally low %CVs (e.g., <5%). LZI's values are mostly in the same low range.
Run-To-Run Semi-quantitative (ng/mL %CV)	150 ng/mL: 4.2%200 ng/mL: 2.4%225 ng/mL: 1.9%250 ng/mL: 2.4%300 ng/mL: 2.1%375 ng/mL: 1.9%	100 ng/mL: 3.1%200 ng/mL: 4.9%300 ng/mL: 4.8%400 ng/mL: 3.3%	Comparable %CV to predicate; generally low %CVs (e.g., <5%). LZI's values are mostly in the same low range.
Sensitivity	20 ng/mL	25 ng/mL	Similar sensitivity to the predicate device.
Accuracy	Vs. a commercial EIA: 95.6% agreement (positive), 99% agreement (negative)	Vs. Syva (n=105): 91.1% agreement (positive), 100% agreement (negative)	High agreement with predicate device (syva). "100% vs. GC/MS /HPLC" for positive samples is a key benchmark.
Analytical Recovery	Qualitative: 100% accuracy on positive vs. negative testsSemi-quantitative: Quantitates within ±15% of nominal concentration between 40 ng/mL and 900 ng/mL	Qualitative: 100% accuracy on positive vs. negative testsSemi-quantitative: Quantitates within ±15% of nominal concentration between 40 ng/mL and 800 ng/mL	Both qualitative and semi-quantitative recovery consistent with industry standards and predicate device.
Specificity	See attached Syva's Barbiturate Assay package insert	Comparable to the predicate device.	Specificity should be comparable to the predicate, implying minimal cross-reactivity to common drugs.

Study Proving Device Meets Acceptance Criteria:

The provided document describes a study comparing the Lin-Zhi International (LZI) Barbiturate Enzyme Immunoassay to a legally marketed predicate device, the Syva EMIT® II Plus Barbiturate Assay (K010934). The studies evaluated precision, sensitivity, accuracy, analytical recovery, and specificity. The conclusion states: "All the studies showed acceptable results when compared to the predicate device."

Summary of Study Information:

Sample size used for the test set and the data provenance:
- Test Set Size: For accuracy, the test set size was n=105 samples against the Syva predicate device. Specific sample sizes for precision studies (e.g., number of replicates for within-run and run-to-run) are not explicitly stated, but the tables show "Mean," "SD," and "%CV" which implies multiple measurements.
- Data Provenance: Not explicitly stated (e.g., country of origin). The document implies the tests were conducted by Lin-Zhi International, Inc.
- Retrospective or Prospective: Not explicitly stated, though performance characteristic studies like these are typically conducted prospectively with defined protocols.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For accuracy, the LZI device was compared against the Syva predicate and also against GC/MS (Gas Chromatography/Mass Spectrometry) / HPLC (High-Performance Liquid Chromatography) for positive samples, where it showed 100% agreement. GC/MS is considered the "preferred confirmatory method" and generally serves as the gold standard / ground truth for drug detection. The number of experts interpreting these GC/MS/HPLC results is not specified, nor are their qualifications. For in-vitro diagnostic devices, the analytical methods themselves establish the ground truth, rather than human experts in the traditional sense, though lab personnel operating these instruments would be qualified.
Adjudication method for the test set:
- Not applicable as this is an in-vitro diagnostic device. Analytical results are compared quantitatively, not through expert adjudication of images or clinical assessments.
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, an MRMC study was not done. This device is an in-vitro diagnostic immunoassay, not an AI-powered diagnostic imaging or decision support tool that involves human "readers" or AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone performance study was done. The entire "Performance Characteristics" section details the analytical performance of the LZI Barbiturate Enzyme Immunoassay as a standalone device. The device itself (the immunoassay) produces quantitative or qualitative results. Human interpretation is primarily for clinical context, but the analytical performance is intrinsic to the device.
The type of ground truth used:
- For accuracy, the ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) / High-Performance Liquid Chromatography (HPLC) for positive samples, and comparison to the predicate device's performance for overall agreement. These are highly specific and sensitive analytical methods considered definitive for drug identification and quantification.
The sample size for the training set:
- This document describes a pre-market notification for an immunoassay, which typically does not involve "training sets" in the context of machine learning. The assay's parameters (e.g., antibody binding, enzyme conjugates, cutoff values) are developed through R&D and optimized, but a distinct "training set" of samples as used in AI/ML is not directly applicable or described. Calibration is performed using known concentrations of secobarbital, but this is for assay operation, not "training" an algorithm.
How the ground truth for the training set was established:
- As noted above, a "training set" as defined for AI/ML is not applicable. The ground truth for calibration standards and controls (which are analogous to the known inputs) for the calibrators and controls used in the LZI Barbiturate EIA are based on known concentrations of secobarbital spiked into a urine matrix. The nominal concentrations are described as "determined and confirmed by GC/MS" (mentioned for the calibrators and controls product).

Summary

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NOV - 3 2003

K632764

September 1, 2003

Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Blvd. Rockville, Maryland 20850

RE: Premarket Notification [510(k)] for Barbiturate Enzyme Immunoassa

Attention: Document Control Clerk

In accordance with the requirements of the Section 510(k) of the Federal Fod Cosmetic Act, Lin-Zhi International, Inc. hereby notifies you of its intention to introdu into interstate commerce for commercial distribution of the Barbiturate Enzyme Immunoassay for qualitative and semi-quantitative determination of barbiturates in human urine.

This test kit is based on the principle of specific inhibition of enzyme activity of an enzyme-drug conjugate by the specific antibody to the drug, which is identical to the homogeneous enzyme immunoassay currently available Emit® II Plus Barbiturate Assay by Syva Company (Dade Behring Inc.) in the commercial distribution.

The following information is being submitted in conformance to the requirements of 21 CFR 807.87:

1.	Classification Name:Common/Usual Name:	Barbiturate Test SystemHomogeneous enzyme immunoassay for the determinationof Barbiturates levels in urine.
	Proprietary Name:	None
	2. EstablishmentRegistration Number:	3003610499
	3. Classification:	The Barbiturate test system has been placed in Class IIby the Bureau of Medical Devices.Classification Number: DIS (21 CFR 862.3150)Panel: 91 Toxicology
	4. Performance Standards:	No applicable standards have been established under Section 51- of the Act.

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510(k) Summary of Safety and Effectiveness

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.

Introduction

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

Submitter name, Address, and Contact

Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 Fax: (408) 732-3849

Contact:	Cheng-I Lin, Ph.D.President, R&D Director
----------	-----------------------------------------------

Device Name and Classification

Classification Name:	Barbiturate test system, Class II,DIS (91 Toxicology),21CFR 862.3150
Common Name:	Homogeneous enzyme immunoassay for the determination ofBarbiturates levels in urine.
Proprietary Name:	None

Legally Marketed Predicate Device(s)

Lin-Zhi International, Inc.' Barbiturate Enzyme Immunoassay is substantially equivalent to Syva EMIT® II Plus Barbiturate Assay (By Syva Company-Dade Behring Inc.), cleared under premarket notification K010934.

LZI's Barbiturate Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.

Device Description

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Intended Use

The Barbiturate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of barbiturates in human urine.

Comparison to Predicate Device

LZI's Barbiturate Enzyme Immunoassay is substantially equivalent to other products in commercially distribution intended for similar use. Most notably it is substantially equivalent to the currently, commercially marketed Emit® II Plus Barbiturate Assay (K010934) by Syva Company-Dade Behring Inc.

The following table compares LZI's Barbiturate Enzyme Immunoassay with the predicate device, Emit® II Plus Barbiturate Assay by Syva Company-Dade Behring Inc.

Similarities:

. Both assays are for qualitative and semi-quantitative determination of barbiturates in human urine.
Both have dual cutoff design (200 ng/mL or 300 ng/mL). .
Both assays use 5 points calibration for semi-quantitative determination. .
Both assays use secobarbital as calibrators and controls. ●
Both assays use the same method principle, and device components. .

Difference:

. Syva's assay uses 150, 225, 250, 375 ng/mL for various control levels. LZI's assay uses 100, 200, 300, 400 ng/mL for various control levels.
Syva's assay uses 0, 100, 200, 300 and 800 ng/mL, LZI's assay uses 0, 100, . 200, 300 and 1000 ng/mL 5 points calibration for semi-quantitative assay.

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Performance Characteristics

Feature	SYVA's Barbiturate EIA				LZI's Barbiturate EIA
Within Run Precision:
Qualitative:	(mA/min.)	Mean	SD	% CV	(mA/min.)	Mean	SD	% CV
	Negative	205.8	0.9	0.4	Negative	269.1	2.2	0.8
	150 ng/mL	242.1	1.0	0.4	100 ng/mL	311.1	1.9	0.6
	200 ng/mL	258.4	1.2	0.5	200 ng/mL	354.2	3.7	1.1
	225 ng/mL	266.9	1.1	0.4	300 ng/mL	385.1	3.1	0.1
	250 ng/mL	276.4	1.2	0.4	400 ng/mL	404.7	2.9	0.7
	300 ng/mL	295.8	1.4	0.5	1000 ng/mL	445.3	2.7	0.6
	375 ng/mL	326.4	1.2	0.4
Semi-quantitative:	(ng/mL)	Mean	SD	%CV	(ng/mL)	Mean	SD	%CV
	150 ng/mL	144.0	5.5	3.8	100 ng/mL	99.0	4.7	4.8
	200 ng/mL	191.4	3.5	1.8	200 ng/mL	194.7	7.4	3.8
	225 ng/mL	215.7	3.2	1.5	300 ng/mL	294.3	8.3	2.8
	250 ng/mL	242.6	3.4	1.4	400 ng/ml	386.5	13.7	3.6
	300 ng/mL	297.9	4.0	1.3	Secobarb only
	375 ng/mL	390.1	3.8	1.0
Run-To-Run Precision:
Qualitative:	(mA/min.)	Mean	SD	% CV	(mA/min.)	Mean	SD	% CV
	Negative	205.8	1.2	0.6	Negative	271.1	2.3	0.8
	150 ng/mL	242.1	1.4	0.6	100 ng/mL	314.8	2.2	0.7
	200 ng/mL	258.4	1.5	0.6	200 ng/mL	359.0	1.9	0.5
	225 ng/mL	266.9	1.7	0.6	300 ng/mL	389.5	1.7	0.4
	250 ng/mL	276.4	1.7	0.6	400 ng/mL	405.6	1.8	0.4
	300 ng/mL	295.8	1.9	0.6	1000 ng/mL	447.4	1.6	0.4
	375 ng/mL	326.4	2.3	0.7		P 13
Semi-quantitative:	(ng/mL)	Mean	SD	%CV	(ng/mL)	Mean	SD	%CV
	150 ng/mL	144.0	6.0	4.2	100 ng/mL	102.7	3.2	3.1
	200 ng/mL	191.4	4.5	2.4	200 ng/mL	191.6	9.3	4.9
	225 ng/mL	215.7	4.1	1.9	300 ng/mL	290.3	14.0	4.8
	250 ng/mL	242.6	5.8	2.4	400 ng/ml	385.3	12.7	3.3
	300 ng/mL	297.9	6.2	2.1			P. 19
	375 ng/mL	390.1	7.3	1.9
Sensitivity:	20 ng/mL				25 ng/mL
Accuracy:	Vs. a commercial EIA				Vs. Syva (n=105)
Positive Samples:	95.6 % agreement				91.1 % agreement(100% vs. GC/MS /HPLC)
Negative Samples:	99% agreement				100 % agreement
Analytical Recovery:
	Qualitative: 100 % accuracy on positive vs. negative tests				100 % accuracy on positive vs. negative tests
Semi-quantitative	Quantitates within ±15% of the nominal				Quantitates within ±15% of the nominal
	concentration between 40 ng/mL and 900				concentration between 40 ng/mL and 800
	ng/mL.				ng/mL.

Specificity:	See attached Syva's Barbiturate Assay				Comparable to the predicate device.
	package insert

the life

រូប

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Conclusion

LZI's Barbiturate Enzyme Immunoassay was evaluated for several performance characteristics including precision, sensitivity, accuracy, analytical recovery, and specificity. All the studies showed acceptable results when compared to the predicate device.

We trust the information provided in this Premarket Notification [510(k)] submission will support a determination of substantial equivalence of the LZI's Barbiturate Enzyme Immunoassay to other Barbiturate test systems currently marketed in the United States.

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510(k) Summary of Safety and Effectiveness

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.

Introduction

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

Submitter name, Address, and Contact

Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 Fax: (408) 732-3849

Contact:	Cheng-I Lin, Ph.D
	President

Device Name and Classification

(a) Classification Name:	Calibrators, Drug Specific;Class II, DLJ (91 Toxicology), 21 CFR 862.3200
Common/Usual Name:	Secobarbital Calibrators
Proprietary Name:	None
(b) Classification Name:	Single (Specified) Analyte Controls (Assayed and Unassayed);Class I, LAS (91 Toxicology), 21 CFR 862.3280
Common/Usual Name:	Secobarbital Controls
Proprietary Name:	None

Legally Marketed Predicate Device(s)

Lin-Zhi International, Inc.'s Barbiturate Urine Drugs of Abuse Calibrators and Controls are substantially equivalent to the DRI's secobarbital calibrators and controls included in the Multi-Drugs Urine Calibrators and Controls (Diagnostic Reagents, Inc., now Microgenics Corporation), cleared under premarket notifications (K935101) for Drugs of Abuse Urine Calibrators and Controls.

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Device Description

The Negative DAU calibrator is a processed, drug-free human urine matrix, which has also been used with all assays. The calibrators and controls are prepared by spiking known concentrations of drug analyte into the Negative DAU Calibrator matrix. The concentrations of drug analyte in the barbiturate calibrators and controls are summarized as follows:

	Barbiturate EIA
Reference Material	Secobarbital
Calibrator #2/Control I	100 ng/mL
Calibrator #3/Cutoff A/Control II	200 ng/mL
Calibrator #4/Cutoff B/Control III	300 ng/mL
Calibrator #5	1000 ng/mL
Control IV	400 ng/mL

Intended Use

The Barbiturate DAU Calibrators are intended for in vitro diagnostic use for the calibration of the barbiturate enzyme immunoassay to detect barbiturates in human urine. The Barbiturate DAU Controls are intended for in vitro diagnostic use for the validation of the barbiturate enzyme immunoassay to detect barbiturates in human urine.

Comparison to Predicate Device

LZI's Barbiturate DAU Calibrators and Controls are similar in intended use, matrix, and performance to the DRI's secobarbital calibrators and controls included in the Multi-Drug Urine Calibrators and Controls.

Similarities:

Both are for the calibration of Barbiturate Enzyme Immunoassay to detect ● drug of abuse in human urine.
A total of 5 levels of calibrators including the negative calibrator for each analyte. ●
The nominal concentrations of the analyte in the calibrators and controls are determined and ● confirmed by GC/MS.
Both are urine-based liquids. ●
Storage condition is the same, at 2℃ to 8℃. ●
Performance characteristics on precision, accuracy and stability are similar. ●

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Differences:

The DRI's cutoff concentration is 200 ng/mL; LZI has 200 and 300 ng/mL cutoffs. .
For semi-quantitative assay, DRI uses 0, 100, 200, 500, and 1000 ng/mL as calibrators. . LZI uses 0, 100, 200, 300, and 1000 ng/mL as calibrators.
LZI uses 100 and 300 ng/mL as controls for 200 ng/mL cutoff, and uses 200 and 400 . ng/mL as controls for 300 ng/mL cutoff. DRI uses 150 and 300 ng/mL as controls for 200 ng/mL cutoff calibrator.

Conclusion

The information provided in the premarket notification demonstrates that the LZI's Barbiturate Drug of Abuse Calibrators and Controls are substantially equivalent to previously approved predicate devices, notably the DRI's Multi-Drug Urine Calibrators and Controls, and safe and effective for its intended use.

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5. Product Description:	Draft copies of(Attachment A) Product Insert, and(Attachment B) Product Labels, are submitted along with(Attachment C) Product Inserts from(i) Emit® II Plus Barbiturate Assay (by DadeBehring Inc.),(ii) Barbiturate Enzyme Immunoassay (DRI)
6. Substantial Equivalence:	The test kit utilizes specific antibody and antigen-enzymeconjugate binding principle identical to those used in theEnzyme Multiplied Immunoassay Technology (EMIT®).The reagent formulation is similar to those described inthe Emit® II Plus Barbiturate Assay (by Dade BehringInc.). Examination of the enclosed data will indicate thatthe current Barbiturate Enzyme Immunoassay issubstantially equivalent to other commercially availabletest kits for determination of barbiturates in human urine.

5. Product Description:

Draft copies of(Attachment A) Product Insert, and(Attachment B) Product Labels, are submitted along with(Attachment C) Product Inserts from(i) Emit® II Plus Barbiturate Assay (by DadeBehring Inc.),(ii) Barbiturate Enzyme Immunoassay (DRI)

6. Substantial Equivalence:

The test kit utilizes specific antibody and antigen-enzymeconjugate binding principle identical to those used in theEnzyme Multiplied Immunoassay Technology (EMIT®).The reagent formulation is similar to those described inthe Emit® II Plus Barbiturate Assay (by Dade BehringInc.). Examination of the enclosed data will indicate thatthe current Barbiturate Enzyme Immunoassay issubstantially equivalent to other commercially availabletest kits for determination of barbiturates in human urine.

We trust the information that we have provided is satisfactory and look forward to your review of this submission.

Furthermore, a truthful and accurate statement, a 510 (k) summary, and an indications for use statement regarding to the current Barbiturate Enzyme Immunoassay are also submitted in accordance to the requirements of the 21 CFR 807.87(J), SMDA 1990, and 21 CFR807.92.

Sincerely,

Chang-Li Lin, Ph.D.

Cheng-I Lin, Ph.D. President, R&D Director Lin-Zhi International, Inc.

Confidentiality

Lin-Zhi International requests the FDA not to disclose the nature or existence of the Premarket Notification until the substantial equivalence decision has been reached.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/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 human profiles embedded within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

NOV - 3 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Cheng-I Lin, Ph.D. President, R & D Director Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085

Re: K032764

Trade/Device Name: Barbiturate Enzyme Immunoassay Barbiturate Drug of Abuse Calibrators and Controls Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS; DLJ; LAS Dated: September 1, 2003 Received: September 5, 2003

Dear Dr. Lin:

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 (OS) 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 Butman

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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Premarket Notification Supplement

Indications for Use Statement

KO32769 510(k) Number (if known): _

Device Name: Barbiturate Drug of Abuse Calibrators and Controls

Indications for Use:

The Barbiturate Drug of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine.

The Barbiturate Drug of Abuse Controls are intended for in vitro diagnostic use for the validation of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Albert Cati

Division Sign-Off for Jean Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032764

Page 2

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Premarket Notification

Indications for Use Statement

510(k) Number (if known):

Device Name: Barbiturate Enzyme Immunoassay

Indications for Use:

Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

Albert Cill'\nDivision Sign-Off to. Jean Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

Concurrence of CDRH, Office of

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.3150 Barbiturate test system.

(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).