The Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene (BMBP) Multiple Analyte Enzyme Immunoassay is a homogeneous enzyme immunoassay. The assay is solely intended for use in the qualitative screening human urine samples for the presence of barbiturates, methadone. benzodiazepines, and propoxyphene drugs. . The assay will produce a positive result if any of the four analyte are present at a concentration at or above their respective cutoffs but will not its its is is is is drug is present. The assay is solely intended for the qualitative screening of human writer for these analytes. Measurements obtained by this device are used in the diagnosis and treatment of in divisiouals who have used barbiturates, methadone, benzodiazepines, and propoxyphene druation on mourvis designed for professional use with a number of automated clinical chemistry arralyzes.

The Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay provides only a preliminary analytical test result. The assay will not identify which drug is present in the positive urine sample. All screening positive samples shall subject to minist assays to identify the drug in the sample before alternative confirmation. Gas chromations withings spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, when preliminary positive results are used.

Device Description

LZI's Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect barbiturates, methadone, benzodiazepines, and propoxyphene drugs in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.

The assay is based on competition between drug 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 enzymc 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 convert nicotinamide adenine dinucleotide (NAD) to NADH.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the BMBP Enzyme Immunoassay:

Acceptance Criteria and Device Performance for BMBP Enzyme Immunoassay

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state numerical "acceptance criteria" for precision or sensitivity in the same way it defines cutoffs. Instead, it presents performance data for the new BMBP EIA and compares it to predicate devices. The implicit acceptance criteria appear to be substantial equivalence to the predicate devices and demonstrating acceptable precision and accuracy.

Note: The accuracy for the BMBP EIA is reported relative to the LZI individual EIAs, while the predicate EIAs' accuracy is often reported against a "commercial EIA" or GC/MS/HPLC, indicating a different primary comparative method in some cases.

Feature	Analyte	Acceptance Criteria (Implicit/Reference)	BMBP Enzyme Immunoassay Performance
Cutoff	Secobarbital	200 ng/mL	200 ng/mL
	Methadone	300 ng/mL	300 ng/mL
	Oxazepam	200 ng/mL	200 ng/mL
	Propoxyphene	300 ng/mL	300 ng/mL
Precision	Within Run	% CV comparable to predicate device	Barbiturate: 0.59% - 0.88% (vs. Predicate: 0.60% - 1.05%)
(n=21)			Methadone: 0.58% - 0.90% (vs. Predicate: 0.25% - 0.49%)
			Benzodiazepine: 0.56% - 0.75% (vs. Predicate: 0.73% - 0.86%)
			Propoxyphene: 0.72% - 0.86% (vs. Predicate: 0.39% - 0.61%)
	Run-to-Run	% CV comparable to predicate device	Barbiturate: 0.42% - 0.90% (vs. Predicate: 0.35% - 0.88%)
(n=12)			Methadone: 0.65% - 0.99% (vs. Predicate: 0.51% - 0.84%)
			Benzodiazepine: 0.66% - 0.95% (vs. Predicate: 0.51% - 4.42% (anomaly for 100 ng/mL))
			Propoxyphene: 0.35% - 0.73% (vs. Predicate: 0.55% - 1.07%)
Sensitivity	Secobarbital	50 ng/mL (same as predicate)	50 ng/mL
	Methadone	75 ng/mL (vs. predicate's 15 ng/mL)	75 ng/mL
	Oxazepam	25 ng/mL (vs. predicate's 15 ng/mL)	25 ng/mL
	Propoxyphene	50 ng/mL (vs. predicate's 15 ng/mL)	50 ng/mL
Accuracy	Positive	100% agreement with predicate device	Barbiturate: 100% agreement (vs. LZI Barbiturate EIA)
			Methadone: 100% agreement (vs. LZI Methadone EIA)
			Benzodiazepine: 100% agreement (vs. LZI Benzodiazepine EIA)
			Propoxyphene: 100% agreement (vs. LZI Propoxyphene EIA)
	Negative	High agreement with predicate device	Barbiturate: 92.5% agreement (vs. LZI Barbiturate EIA)
			Methadone: 95.0% agreement (vs. LZI Methadone EIA)
			Benzodiazepine: 97.5% agreement (vs. LZI Benzodiazepine EIA)
			Propoxyphene: 97.5% agreement (vs. LZI Propoxyphene EIA)
Analytical	Positive/Negative	100% accuracy	100% accuracy on positive vs. negative tests (for all analytes)
Recovery
Specificity	Comparable to predicate device	See attached Assay package insert

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

Precision (within-run): n=21 replicates at each concentration level (Negative, 100/225 ng/mL, 200 ng/mL, 300/375 ng/mL, 1000 ng/mL) for each analyte.
Precision (run-to-run): n=12 replicates at each concentration level for each analyte.
Accuracy: The document states "Positive Samples: 100 % agreement" and "Negative Samples: [various percentages] agreement" but does not specify the number of samples used for the accuracy assessment against the predicate devices.
Data Provenance: Not explicitly stated. Given the context of a 510(k) submission for a diagnostic device, these would typically be laboratory-generated or spiked urine samples. Country of origin is not mentioned but assumed to be from within the company's testing facilities (likely US based on the submission to FDA). The study is prospective in the sense that controlled experiments were performed to gather this data for the submission.

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

N/A. This is an in-vitro diagnostic (IVD) device for drug detection. The "ground truth" for the test set is established by the known concentrations of the target analytes in the samples, or by results from a reference method like GC/MS or a commercial EIA (for the predicate device's ground truth). Human expert interpretation is not part of establishing the ground truth for this type of test.

4. Adjudication Method for the Test Set

N/A. As this is an IVD device measuring analyte concentrations, there is no expert adjudication process for the test results. The results are quantitative (mA/min) and then interpreted qualitatively (positive/negative) based on a defined cutoff.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

N/A. This is an automated immunoassay for drug detection, not an imaging device or a test requiring human interpretation. Therefore, an MRMC study is not applicable. The device operates standalone.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes, this is a standalone device. The BMBP Enzyme Immunoassay performs the detection of drugs in urine automatically. Its performance characteristics (precision, sensitivity, accuracy, analytical recovery, and specificity) are evaluated as a standalone system. The stated intended use is for "qualitative screening human urine samples" with results interpreted automatically against defined cutoffs. It is intended for "professional use with a number of automated clinical chemistry analyzers."

7. Type of Ground Truth Used

The ground truth used for performance validation includes:

Known concentrations: For precision and sensitivity studies, samples with predefined concentrations of the target drugs were likely used.
Comparison to predicate devices: For accuracy, the results from the new BMBP EIA were compared to results obtained from the individual LZI predicate EIAs.
Reference Methods (for predicate's accuracy): The predicate devices themselves sometimes reference GC/MS/HPLC or other commercial EIAs for their own accuracy establishment. For example, the LZI Methadone EIA's positive sample accuracy is 100% agreement "vs. GC/MS /HPLC".

8. Sample Size for the Training Set

Not explicitly mentioned in the provided text. For enzyme immunoassays, there isn't a "training set" in the machine learning sense. Instead, the assay's operational parameters (e.g., reagent concentrations, reaction times, spectrophotometer readings, and cutoff values) are developed and optimized during the research and development phase using a range of experimental samples. The document focuses on the validation of the final device, not its initial development.

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

Not applicable in the context of "training set" for an enzyme immunoassay. The development process would involve:

Known spiked samples: Urine samples spiked with precise concentrations of target analytes and potential interfering substances.
Clinically characterized samples: Real patient samples with known drug status (confirmed by a reference method like GC/MS).
The ground truth would be established by these known concentrations or confirmed reference method results, which are then used to optimize and set the assay's parameters, including its cutoff.

Summary

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K033885

MAY 1 9 2004

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

1. Classification Name:	Barbiturate, Methadone, Benzodiazepine, andPropoxyphene test systems
	The Barbiturate test system has been placed in Class II by theBureau of Medical Devices.Classification Number: DIS (21 CFR 862.3150)Panel: 91 Toxicology
	The Methadone test system has been placed in Class II by theBureau of Medical Devices.Classification Number: DJR (21 CFR 862.3620)Panel: 91 Toxicology
	The Benzodiazepine test system has been placed in Class II bythe Bureau of Medical Devices.Classification Number: JXM (21 CFR 862.3170)Panel: 91 Toxicology
	The Propoxyphene test system has been placed in Class II bythe Bureau of Medical Devices.Classification Number: JXN (21 CFR 862.3700)Panel: 91 Toxicology

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Common Name:	Homogeneous enzyme immunoassay for the detection ofbarbiturates, methadone, benzodiazepines, and propoxyphenein human urine.
Proprietary Name:	BMBP Enzyme Immunoassay

Legally Marketed Predicate Device(s)

Lin-Zhi International, Inc.'s Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay is substantially equivalent to the individual Barbiturate Enzyme Immunoassay, Methadone Enzyme Immunoassay, Benzodiazepine Enzyme Immunoassay, and Propoxyphene Enzyme Immunoassay by Lin-Zhi International, Inc., cleared under premarket notification K032764 (Barbiturate Enzyme Immunoassay), K023317 (Methadone Enzyme Immunoassay), K032365 (Benzodiazepine Enzyme Immunoassay), and K023795 (Propoxyphene Enzyme Immunoassay).

LZI's Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay is similar to their predicates in terms of intended use, method principle, device components, and clinical performance.

Device Description

Intended Use

The Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay is a homogeneous enzyme immunoassay, with 200 ng/mL cutoff for secobarbital, 300 ng/mL cutoff for methadone, 200 ng/mL cutoff for oxazepam, and 300 ng/mL cutoff for propoxyphene. The assay is solely intended for use in the qualitative screening human urine samples for the presence of barbiturates, methadone, benzodiazepine, and propoxyphene drugs.

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Comparison to Predicate Device

LZI's Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay is substantially equivalent to the individual single analyte assay products in commercially distribution intended for similar use. Most notably it is substantially equivalent to the Barbiturate Enzyme Immunoassay, Methadone Enzyme Immunoassay, Benzodiazepine Enzyme Immunoassay, and Propoxyphene Enzyme Immunoassay by Lin-Zhi International, Inc., cleared under pre-market notification K032764 (Barbiturate Enzyme Immunoassay), K0233174(Methadone Enzyme Immunoassay), K032365 (Benzodiazepine Enzyme Immunoassay), and K023795 (Propoxyphene Enzyme Immunoassay).

The following table compares LZI's Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene (BMBP) Multiple Analyte Enzyme Immunoassay with the predicate devices, Barbiturate Enzyme Immunoassay, Methadone Enzyme Immunoassay, Benzodiazepine Enzyme Immunoassay, and Propoxyphene Enzyme Immunoassay by Lin-Zhi International, Inc.

Similarities:

Both assays are used for qualitative detection of drug in human urine. .
Both have same cutoff design (200 ng/mL for secobarbital, 300 ng/mL for . methadone, 200 ng/mL for oxazepam, and 300 ng/mL for propoxyphene).
. Both assays use same control concentration.
Both assays use the same method principle, and device components. .

Difference:

. Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay is designed for qualitative screening purpose only.
The assay is for positive/negative screening only. Positive samples need further . test to identify individual drug in the sample.
Multiple analyte calibrators/controls cannot be use in this assay. .
Any single analyte calibrators and controls (secobarbital, methadone, oxazepam, . or propoxyphene) can be used to verify and validate this assay.

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Performance Characteristics

Feature	LZI's BMBP EIA			LZI's Barbiturate EIA
Within Run Precision:(n=21)	(mA/min.)	Mean	SD	% CV	(mA/min.)	Mean	SD	% CV
	Negative	598.8	3.52	0.59	Negative	269.1	2.16	0.80
	100 ng/mL	625.2	5.53	0.88	100 ng/mL	311.1	1.92	0.62
	200 ng/mL	659.9	5.52	0.84	200 ng/mL	354.2	3.71	1.05
	300 ng/mL	679.2	5.47	0.81	300 ng/mL	385.1	3.07	0.80
	1000 ng/mL	722.9	3.79	0.52	1000 ng/mL	445.3	2.69	0.60
Run-To-Run Precision:(n=12)	(mA/min.)	Mean	SD	% CV	(mA/min.)	Mean	SD	% CV
	Negative	600.0	5.31	0.88	Negative	271.1	2.3	0.83
	100 ng/mL	624.4	2.63	0.42	100 ng/mL	314.8	2.2	0.69
	200 ng/mL	653.3	4.18	0.64	200 ng/mL	359.0	1.9	0.53
	300 ng/mL	681.2	5.70	0.84	300 ng/mL	389.5	1.6	0.42
	1000 ng/mL	726.5	6.53	0.90	1000 ng/mL	447.4	1.6	0.35
Sensitivity:	50 ng/mL				25 ng/mL
Accuracy:	Vs. LZI Barbiturate EIA				Vs. a commercial EIA
	Positive Samples: 100 % agreement				91.1 % agreement
	Negative Samples: 92.5 % agreement				100 % agreement
Analytical Recovery:	100 % accuracy on positive vs. negative tests				100 % accuracy on positive vs. negative tests
Specificity:	See attached Assay package insert				Comparable to the predicate device.

Feature		LZI's BMBP EIA	LZI's Methadone EIA
Within Run Precision:	(mA/min.)	Mean	SD	% CV	(mA/min.)	Mean	SD	% CV
(n=21)	Negative	596.3	4.27	0.72	Negative	209.4	1.0	0.49
	225 ng/mL	638.5	5.77	0.90	225 ng/mL	272.8	1.1	0.39
	300 ng/mL	657.3	3.80	0.58	300 ng/mL	293.4	0.7	0.25
	375 ng/mL	673.2	4.06	0.60	375 ng/mL	308.2	0.9	0.29
	1000 ng/mL	715.6	5.30	0.74	1000 ng/mL	344.9	1.1	0.33
Run-To-Run Precision:	(mA/min.)	Mean	SD	% CV	(mA/min.)	Mean	SD	% CV
(n=12)	Negative	600.3	5.94	0.99	Negative	209.5	1.1	0.51
	225 ng/mL	640.0	5.45	0.85	225 ng/mL	271.4	2.0	0.74
	300 ng/mL	658.7	4.29	0.65	300 ng/mL	292.3	1.9	0.66
	375 ng/mL	673.3	5.30	0.79	375 ng/mL	307.2	2.6	0.84
	1000 ng/mL	707.3	5.00	0.71	1000 ng/mL	344.1	2.0	0.58
Sensitivity:	75 ng/mL				15 ng/mL
Accuracy:	Vs. LZI Methadone EIA		Vs. a commercial EIA
Positive Samples:	100 % agreement		100 % agreement (100% vs. GC/MS /HPLC)
Negative Samples:	95.0 % agreement				100 % agreement
Analytical Recovery:	100 % accuracy on positive vs. negative tests				100 % accuracy on positive vs. negative tests
Specificity:	See attached Assay package insert				Comparable to the predicate device.

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Feature	LZI's BMBP EIA				LZI's Benzodiazepine EIA
Within Run Precision:(n=21)	(mA/min.)	Mean	SD	% CV	(mA/min.)	Mean	SD	% CV
	Negative	602.1	3.8	0.64	Negative	361.0	3.1	0.86
	100 ng/mL	635.7	3.6	0.56	100 ng/mL	417.8	3.5	0.84
	200 ng/mL	655.9	4.5	0.68	200 ng/mL	455.5	3.5	0.76
	300 ng/mL	683.7	4.6	0.68	300 ng/mL	483.3	3.5	0.73
	1000 ng/mL	736.1	5.5	0.75	1000 ng/mL	559.7	4.9	0.74
Run-To-Run Precision:(n=12)	(mA/min.)	Mean	SD	% CV	(mA/min.)	Mean	SD	% CV
	Negative	600.8	5.0	0.83	Negative	360.0	2.5	0.70
	100 ng/mL	637.6	4.2	0.66	100 ng/mL	417.9	2.5	4.42
	200 ng/mL	655.6	4.5	0.69	200 ng/mL	457.0	1.9	0.51
	300 ng/mL	683.0	5.3	0.78	300 ng/mL	483.6	2.4	0.55
	1000 ng/mL	739.0	7.0	0.95	1000 ng/mL	561.8	3.3	0.58
Sensitivity:	25 ng/mL				15 ng/mL
Accuracy:	Vs. LZI Benzodiazepine EIA				Vs. a commercial EIA
Positive Samples:	100 % agreement			96.9 % agreement(vs. GC/MS /HPLC)
Negative Samples:	97.5 % agreement					84 % agreement
Analytical Recovery:	100 % accuracy on positive vs. negative tests				100 % accuracy on positive vs. negative tests
Specificity:	See attached Assay package insert				Comparable to the predicate device.

and the comments of the comments of the comments of the comments of

100 - 100 - 100

Feature	LZI's BMBP EIA				LZI's Propoxyphene EIA
Within Run Precision:(n=21)	(mA/min.)	Mean	SD	% CV	(mA/min.)	Mean	SD	% CV
	Negative	600.5	5.19	0.86	Negative	117.4	0.5	0.47
	225 ng/mL	642.5	5.48	0.85	225 ng/mL	225.1	1.3	0.59
	300 ng/mL	656.8	5.54	0.84	300 ng/mL	261.3	1.6	0.61
	375 ng/mL	671.8	4.84	0.72	375 ng/mL	287.7	1.5	0.51
	1000 ng/mL	702.5	5.30	0.75	1000 ng/mL	350.0	1.4	0.39
Run-To-Run Precision:(n=12)	(mA/min.)	Mean	SD	% CV	(mA/min.)	Mean	SD	% CV
	Negative	599.5	4.2	0.70	Negative	116.8	1.0	0.88
	225 ng/mL	642.1	4.3	0.67	220.8	220.8	2.4	1.07
	300 ng/mL	657.7	4.8	0.73	300 ng/mL	255.9	2.1	0.81
	375 ng/mL	671.4	6.3	0.94	375 ng/mL	285.1	2.2	0.76
	1000 ng/mL	707.5	2.5	0.35	1000 ng/mL	349.5	1.9	0.55
Sensitivity:	50 ng/mL				15 ng/mL
Accuracy:	Vs. LZI Propoxyphene EIA				Vs. a commercial EIA
	Positive Samples:100 % agreement				100 % agreement(vs. GC/MS /HPLC)
	Negative Samples:97.5 % agreement				100 % agreement
Analytical Recovery:	100 % accuracy on positive vs. negative tests				100 % accuracy on positive vs. negative tests
Specificity:	See attached Assay package insert				Comparable to the predicate device.

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Conclusion

The LZI's Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte 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 individual 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 Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay to other individual test systems for screening purpose currently marketed in the United States.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping bodies, representing the department's mission to protect the health of all Americans and provide essential human services.

MAY 1 9 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K033885

Trade/Device Name: Simultaneous Barbiturate- Methadonc-Benzodiazepine Propoxyphene(BMBP) Multiple Analyte Enzyme Immunoassay Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS, DJR, JXM, JXN Dated: April 21, 2004 Received: April 27, 2004

Dcar 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 (QS) 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,

Jean M. Cooper, MS, DVM.
MS, DVM

Jean M. Cooper, MS. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

Device Name: Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene (BMBP) Multiple Analyte Enzyme Immunoassay

Indications for Use:

Tan Cooper

ision Sign-Of

Office of In Vitro Diagnostic Device Office of Safety

510(k) < 033883

Prescription Use AND/OR (Per 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of IN Vitro Diagnostic Device (OIVD)

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).