The Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay, when used in conjunction with Beckman Coulter® Synchron LX®, CX®, and UniCel® DxC automated clinical system analyzers, is intended for the qualitative and semi-quantitative determination of norbuprenorphine (buprenorphine metabolite) in human urine, at a cutoff value of 10 ng/mL.

The Norbuprenorphine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay with Beckman Coulter® Synchron LX®, CX®, and UniCel® DxC automated clinical system analyzers.

The Norbuprenorphine Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay with Beckman Coulter® Synchron LX®, CX®, and UniCel® DxC automated clinical system analyzers.

The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method (1,2). Clinical consideration and professional judgement should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

Device Description

The LZI Buprenorphine assay is a homogeneous enzyme immunoassay with ready-to-use liquid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, buprenorphine-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug, the unbound buprenorphine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm

AI/ML Overview

Here's an analysis of the provided text regarding the Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay, Calibrators and Controls:

1. Table of Acceptance Criteria and Reported Device Performance

For an in vitro diagnostic (IVD) device like this immunoassay, acceptance criteria typically revolve around precision (reproducibility) and method comparison (agreement with a gold standard). The provided document presents detailed precision data. While explicit "acceptance criteria" for these values aren't stated as pass/fail thresholds in the summary, the detailed data demonstrates the device's performance characteristics.

The "Method comparison against GC/MS confirmation device" section provides the most direct performance against a ground truth.

Acceptance Criteria (Implied) and Reported Device Performance:

Performance Metric	Implied Acceptance Criterion (Typical for IVD)	Reported Device Performance (LZI Buprenorphine Enzyme Immunoassay)
Precision (Semi-Quantitative)
Within-Run CV% (various concentrations)	Low coefficient of variation (CV%) to indicate high reproducibility within a single run. (e.g., typically <10-20% for low concentrations, <5-10% for higher concentrations, though exact criteria vary by analyte and intended use)	CX4CE Analyzer: CV% ranged from 0.0% (at 0 ng/mL) to 11.2% (at 2.5 ng/mL). LX20 Pro Analyzer: CV% ranged from n/a (at 0 ng/mL) to 13.1% (at 5.0 ng/mL). DxC600 Analyzer: CV% ranged from 0.0% (at 0 ng/mL) to 16.4% (at 2.5 ng/mL). (Overall, CV% is generally very low for higher concentrations, reflecting good precision for quantitative results.)
Run-to-Run CV% (various concentrations)	Low coefficient of variation (CV%) to indicate good reproducibility across different runs. (e.g., typically <10-20% for low concentrations, <5-10% for higher concentrations)	CX4CE Analyzer: CV% ranged from n/a (at 0 ng/mL) to 14.9% (at 2.5 ng/mL). LX20 Pro Analyzer: CV% ranged from 242.2% (at 0 ng/mL, likely due to very low mean value) to 22.6% (at 2.5 ng/mL). DxC600 Analyzer: CV% ranged from 162.1% (at 0 ng/mL, likely due to very low mean value) to 10.0% (at 2.5 ng/mL). (CV% generally improves significantly at concentrations further from 0, indicating better reproducibility away from the detection limit.)
Precision (Qualitative - Positive/Negative)
Within-Run Agreement (at cutoff and near cutoff)	Consistent results (100% Negative below cutoff, 100% Positive above cutoff). Near cutoff, some variability is expected and defined by the "gray zone" around the cutoff.	CX4CE Analyzer: 100% NEG at 0, 2.5, 5.0, 7.5 ng/mL. At 10 ng/mL (Cutoff): 13 POS/8 NEG (21 total). 100% POS at 12.5, 15.0, 17.5, 20.0 ng/mL. LX20 Pro Analyzer: 100% NEG at 0, 2.5, 5.0, 7.5 ng/mL. 100% POS at 10 ng/mL (Cutoff) and above. DxC600 Analyzer: 100% NEG at 0, 2.5, 5.0, 7.5 ng/mL. At 10 ng/mL (Cutoff): 18 POS/3 NEG (21 total). 100% POS at 12.5, 15.0, 17.5, 20.0 ng/mL.
Run-to-Run Agreement (at cutoff and near cutoff)	Consistent results (100% Negative below cutoff, 100% Positive above cutoff). Near cutoff, some variability is expected and defined by the "gray zone" around the cutoff.	CX4CE Analyzer: 100% NEG at 0, 2.5, 5.0, 7.5 ng/mL. At 10 ng/mL (Cutoff): 12 POS/8 NEG (20 total). 100% POS at 12.5, 15.0, 17.5, 20.0 ng/mL. LX20 Pro Analyzer: 100% NEG at 0, 2.5, 5.0, 7.5 ng/mL. 100% POS at 10 ng/mL (Cutoff) and above. DxC600 Analyzer: 100% NEG at 0, 2.5, 5.0, 7.5 ng/mL. At 10 ng/mL (Cutoff): 13 POS/7 NEG (20 total). 100% POS at 12.5, 15.0, 17.5, 20.0 ng/mL.
Method Comparison (vs. GC/MS)
Positive Agreement	High percentage of agreement for samples confirmed positive by GC/MS. (e.g., typically >90-95%)	CX4CE Instrument: 93.0% agreement with positive results. LX20 Pro Instrument: 97.4% agreement with positive results. DxC Instrument: 97.4% agreement with positive results.
Negative Agreement	High percentage of agreement for samples confirmed negative by GC/MS. (e.g., typically >90-95%)	CX4CE Instrument: 97.5% agreement with negative results. LX20 Pro Instrument: 95.3% agreement with negative results. DxC Instrument: 95.3% agreement with negative results.
Detection Limit	Low detection limit for clinical relevance and to ensure identification of drug presence at therapeutically relevant or abuse levels.	Determined as 3 ng/mL on all three platforms of instruments with 95% confidence.
Linearity Range	A broad and clinically relevant range over which the assay provides accurate quantitative results.	CX4CE Instrument: 3-90 ng/mL. LX20 Pro Instrument: 3-70 ng/mL. DxC Instrument: 3-70 ng/mL.

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

Precision Studies:
- Semi-Quantitative and Qualitative Precision (Within-Run): n=21 determinations for each concentration level (0 ng/mL to 20 ng/mL) on each of the three analyzer types (CX4CE, LX20 Pro, DxC600).
- Semi-Quantitative and Qualitative Precision (Run-to-Run): n=20 determinations over 2 weeks for each concentration level (0 ng/mL to 20 ng/mL) on each of the three analyzer types.
Method Comparison (against GC/MS):
- CX4CE Instrument: 83 clinical unaltered samples.
- LX20 Pro Instrument: 82 clinical unaltered samples.
- DxC Instrument: 83 clinical unaltered samples.
Data Provenance: The document states "clinical unaltered samples" for the method comparison, implying human urine samples. There is no information provided about the country of origin or whether the data was retrospective or prospective.

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

This type of immunoassay device does not typically involve human "experts" establishing ground truth in the way medical imaging AI might.

For the precision studies, the ground truth (sample concentration) was established by preparing samples to specific known concentrations (e.g., 0, 2.5, 5.0 ng/mL, etc.).
For the method comparison study, the ground truth was established by a confirmatory analytical method: Chromatography/mass spectrometry (GC/MS). This is a highly accurate and widely accepted gold standard for drug detection and quantification in biological samples. The expertise implicitly lies in the validated GC/MS method and trained laboratory personnel performing these analyses, rather than individual "experts" reviewing cases.

4. Adjudication Method for the Test Set

Not applicable for this type of IVD device study. The ground truth (GC/MS results or known sample concentration) is determined analytically, not through human consensus or adjudication. Discrepancies between the device and GC/MS would be analyzed statistically rather than adjudicated by experts.

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

Not applicable. This is an in vitro diagnostic device, not an AI or human-in-the-loop diagnostic imaging system. It performs a standalone analytical measurement.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this entire study is a standalone performance assessment of the LZI Buprenorphine Enzyme Immunoassay. It's an "algorithm only" in the sense that the device itself performs the chemical reaction and measurement, yielding a result without direct human intervention in the interpretation of that primary result for a given sample. Humans operate the instrument and interpret the final quantitative or qualitative output, but the core analytical performance is standalone.

7. The Type of Ground Truth Used

Precision Studies: The ground truth was based on known, spiked concentrations of norbuprenorphine in samples.
Method Comparison Study: The ground truth was established using Chromatography/mass spectrometry (GC/MS), which is considered the gold standard for confirmatory drug testing.

8. The Sample Size for the Training Set

No information about a "training set" is provided. This is typical for traditional IVD devices. The device's performance characteristics (e.g., standard curves, reagent formulations) are developed and optimized by the manufacturer, but the regulatory submission focuses on the validation or test set performance. There isn't a "machine learning" training phase in the context of this immunoassay.

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

Not applicable, as no training set (in the machine learning sense) is explicitly described for this traditional IVD device. The underlying chemical principles and instrument calibration guide its function, rather than data-driven machine learning.

Summary

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DEC 2 2 2008

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 (408) 732-3849 Fax: Email: mtlin@lin-zhi.com

Marie Lin, Ph.D. Contact: President, R&D Director

Device Name and Classification

Classification Name:	Enzyme immunoassay, OpiatesClass II, DJG (91 Toxicology),21 CFR 862.3650Norbuprenorphine calibrators,Class II, DLJ (91 Toxicology),21 CFR 862.3200Norbuprenorphine controls,Class I, LAS (91 Toxicology),21 CFR 862.3280
Common Name:	Homogeneous Buprenorphine Enzyme Immunoassay
Proprietary Name:	LZI Buprenorphine Enzyme Immunoassay, Calibrators andControls: for Beckman Coulter® Synchron Systems

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Legally Marketed Predicate Device(s)

The LZI Buprenorphine Enzyme Immunoassay (EIA) is substantially equivalent to the CEDIA® Buprenorphine Assay (K040316) manufactured by Microgenics Corporation. LZI's Buprenorphine Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.

Device Description

Intended Use

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Comparison to Predicate Device

The LZI Buprenorphine Enzyme Immunoassay is substantially equivalent to the CEDIA® Buprenorphine Assay (by Microgenics Corporation), cleared by the FDA under the premarket notification K040316 for its stated intended use.

The following table compares LZI's Buprenorphine Enzyme Immunoassay with the predicate device, CEDIA® Buprenorphine Assay by Microgenics Corporation.

DeviceCharacteristics	Subject Device	Predicate Device
	LZI Buprenorphine EnzymeImmunoassay	CEDIA® Buprenorphine Assay(K040316)
	for Beckman Coulter® Synchron Systems
Intended Use	The Lin-Zhi International (LZI)Buprenorphine Enzyme Immunoassay,when used in conjunction with BeckmanCoulter® Synchron LX®, CX®, andUniCel® DxC automated clinical systemanalyzers, is intended for the qualitativeand semi-quantitative determination ofnorbuprenorphine (buprenorphinemetabolite) in human urine, at a cutoffvalue of 10 ng/mL.This assay provides a rapid screening procedurefor determining the presence of norbuprenorphine(buprenorphine metabolite) in urine. The assayprovides only a preliminary analytical result. Amore specific alternative chemical method must beused in order to obtain a confirmed analyticalresult. Chromatography/mass spectrometry(GC/MS or LC/MS) is the preferred confirmatorymethod (1,2). Clinical consideration andprofessional judgement should be exercised withany drug of abuse test result, particularly when thepreliminary test result is positive.	The CEDIA Buprenorphine assay is ahomogeneous enzyme immunoassay forqualitative or semi-quantitativedetermination of the presence ofbuprenorphine in human urine at cutoffconcentration of 5 ng/mL. The assayprovides a simple and rapid analyticalscreening procedure to detectbuprenorphine in human urine.The assay provides only a preliminary analyticalresult. A more specific alternative chemicalmethod must be used to obtain a confirmedanalytical result. Gas chromatography/massspectrometry (GC/MS) is the preferredconfirmatory method. Clinical and professionaljudgement should be applied to any drug of abusetest result, particularly when preliminary resultsare used.
Analyte	Norbuprenorphine (buprenorphinemetabolite)	Buprenorphine
Cutoff	10 ng/ml	5 ng/ml
Matrix	Urine	Urine
CalibratorsLevel	6 Levels(0, 5, 10, 20, 40, 100 ng/mL)	5 Levels(0, 5, 20, 50 and 75 ng/ml)
Controls Level	2 Levels(7 ng/mL, 13 ng/mL)	2 Levels(3 ng/mL, 7 ng/mL)
Storage	2-8°C until expiration date	2-8°C until expiration date

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Performance Characteristics Summary: Precision: Semi-Quantitative, ng/mL

CX4CE Analyzer:

Drug:Norbuprenorphine	Sampleconcentration,ng/mLWithin-Run(n=21)	Mean,ng/mL	SD	CV%		Mean,ng/mLRun-to-Run(n=20 over 2weeks)	SD	CV%
Norbuprenorphine	0	0.0	0.0	0.0	0	0.0	0.1	n/a
Norbuprenorphine	2.5	3.4	0.4	11.2	2.5	3.0	0.4	14.9
Norbuprenorphine	5.0	5.9	0.5	7.9	5.0	5.9	0.4	6.3
Norbuprenorphine	7.5	7.7	0.3	3.9	7.5	7.9	0.5	6.2
Norbuprenorphine	10.0	10.2	0.4	3.5	10.0	10.2	0.5	4.5
Norbuprenorphine	12.5	12.7	0.5	3.7	12.5	12.7	0.3	2.7
Norbuprenorphine	15.0	15.1	0.4	2.4	15.0	15.3	0.6	3.8
Norbuprenorphine	17.5	17.4	0.7	3.8	17.5	17.8	0.4	2.4
Norbuprenorphine	20.0	20.5	0.6	2.9	20.0	20.8	0.6	2.9

LX20 Pro Analyzer:

Drug: Norbuprenorphine	Sample concentration, ng/mL	Mean, ng/mL	SD	CV%		Mean, ng/mL	SD	CV%
	Within-Run (n=21)				Run-to-Run (n=20 over 2 weeks)
Norbuprenorphine	0	0.0	0.1	n/a	0	0.1	0.3	242.2
Norbuprenorphine	2.5	3.6	0.4	9.8	2.5	3.2	0.7	22.6
Norbuprenorphine	5.0	5.5	0.7	13.1	5.0	5.8	0.5	9.3
Norbuprenorphine	7.5	8.1	0.2	2.7	7.5	7.9	0.6	7.3
Norbuprenorphine	10.0	10.7	0.2	2.1	10.0	10.5	0.6	5.6
Norbuprenorphine	12.5	12.8	0.5	3.9	12.5	12.8	0.5	4.1
Norbuprenorphine	15.0	15.2	0.5	3.3	15.0	14.9	0.7	4.4
Norbuprenorphine	17.5	18.6	0.5	2.9	17.5	17.8	0.7	4.0
Norbuprenorphine	20.0	21.0	0.5	2.3	20.0	20.6	1.0	4.6

DxC600 Analyzer:

Drug:Norbuprenorphine	Sampleconcentration,ng/mL	Mean,ng/mL	SD	CV%		Mean,ng/mL	SD	CV%
	Within-Run(n=21)				Run-to-Run(n=20 over 2weeks)
Norbuprenorphine	0	0.0	0.0	0.0	0	0.2	0.4	162.1
Norbuprenorphine	2.5	3.2	0.5	16.4	2.5	3.2	0.3	10.0
Norbuprenorphine	5.0	6.1	0.3	5.1	5.0	6.0	0.3	4.8
Norbuprenorphine	7.5	7.9	0.2	2.5	7.5	7.7	0.3	3.4
Norbuprenorphine	10.0	10.4	0.4	4.2	10.0	10.0	0.3	3.4
Norbuprenorphine	12.5	12.6	0.4	3.4	12.5	12.1	0.3	2.2
Norbuprenorphine	15.0	14.9	0.4	2.4	15.0	14.6	0.4	2.6
Norbuprenorphine	17.5	17.6	0.5	2.9	17.5	17.3	0.5	2.9
Norbuprenorphine	20.0	20.2	0.5	2.5	20.0	20.0	0.4	2.0

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Precision: Qualitative, mA/min

CX4CE Analyzer:

Drug:Norbuprenorphine	Sampleconcentration,ng/mL	Mean,mA/min	SD	CV%		Mean,mA/min	SD	CV%
	Within-Run(n=21)				Run-to-Run(n=20 over 2weeks)
Norbuprenorphine	0	367.4	1.7	0.5	0	366.8	1.9	0.5
Norbuprenorphine	2.5	379.4	1.4	0.4	2.5	378.5	1.5	0.4
Norbuprenorphine	5.0	389.8	2.1	0.5	5.0	390.8	1.0	0.2
Norbuprenorphine	7.5	398.8	1.5	0.4	7.5	400.2	1.8	0.5
Norbuprenorphine	10.0	411.2	1.8	0.4	10.0	412.3	1.7	0.4
Norbuprenorphine	12.5	424.6	2.4	0.6	12.5	425.3	1.6	0.4
Norbuprenorphine	15.0	437.1	1.9	0.4	15.0	438.6	2.0	0.5
Norbuprenorphine	17.5	448.6	3.3	0.7	17.5	451.3	2.1	0.5
Norbuprenorphine	20.0	463.6	2.8	0.6	20.0	465.4	2.2	0.5

LX20 Pro Analyzer:

Drug:Norbuprenorphine	Sampleconcentration,ng/mL	Within-Run(n=21)			Run-to-Run(n=20 over 2weeks)
		Mean,mA/min	SD	CV%	Mean,mA/min	SD	CV%
Norbuprenorphine	0	368.2	1.8	0.5	371.7	3.7	1.0
Norbuprenorphine	2.5	385.8	2.1	0.5	386.2	3.4	0.9
Norbuprenorphine	5.0	398.0	4.9	1.2	401.6	3.0	0.7
Norbuprenorphine	7.5	417.8	1.7	0.4	414.9	3.5	0.8
Norbuprenorphine	10.0	437.6	1.7	0.4	433.7	2.7	0.6
Norbuprenorphine	12.5	452.7	3.5	0.8	450.2	2.4	0.5
Norbuprenorphine	15.0	469.1	3.3	0.7	465.0	2.8	0.6
Norbuprenorphine	17.5	490.3	3.1	0.6	482.9	3.1	0.6
Norbuprenorphine	20.0	503.3	2.5	0.5	498.5	4.0	0.8

DxC600 Analyzer:

Drug:	Sampleconcentration,ng/mL	Mean,mA/min	SD	CV%		Mean,mA/min	SD	CV%
Norbuprenorphine	Within-Run(n=21)				Run-to-Run(n=20 over 2weeks)
Norbuprenorphine	0	378.7	2.4	0.6	0	384.9	3.3	8.6
Norbuprenorphine	2.5	395.1	2.9	0.7	2.5	397.6	2.5	6.3
Norbuprenorphine	5.0	414.6	2.4	0.6	5.0	415.4	2.4	5.7
Norbuprenorphine	7.5	428.4	1.6	0.4	7.5	428.5	2.4	5.7
Norbuprenorphine	10.0	449.1	3.6	0.8	10.0	446.6	2.0	4.6
Norbuprenorphine	12.5	467.5	3.4	0.7	12.5	463.6	1.5	3.3
Norbuprenorphine	15.0	484.9	2.6	0.5	15.0	481.4	2.4	5.0
Norbuprenorphine	17.5	503.3	3.2	0.6	17.5	499.9	2.2	4.4
Norbuprenorphine	20.0	518.7	2.9	0.6	20.0	515.6	2.2	4.3

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CX4CE Analyzer		Within Run		Run to Run
Sample	% of Cutoff	# of Determination	Result	# of Determination	Result
[ ], ng/mL
0	-100%	21	21 NEG	20	20 NEG
2.5	-75%	21	21 NEG	20	20 NEG
5.0	-50%	21	21 NEG	20	20 NEG
7.5	-25%	21	21 NEG	20	20 NEG
10.0	100%	21	13 POS/8 NEG	20	12 POS/8 NEG
12.5	+25%	21	21 POS	20	20 POS
15.0	+50%	21	21 POS	20	20 POS
17.5	+175%	21	21 POS	20	20 POS
20.0	+200%	21	21 POS	20	20 POS

Precision: Qualitative, Positive/Negative

LX20 Pro Analyzer		Within Run		Run to Run
Sample[], ng/mL	% of Cutoff	# ofDetermination	Result	# ofDetermination	Result
0	- 100%	21	21 NEG	20	20 NEG
2.5	- 75%	21	21 NEG	20	20 NEG
5.0	- 50%	21	21 NEG	20	20 NEG
7.5	- 25%	21	21 NEG	20	20 NEG
10.0	100%	21	21 POS	20	20 POS
12.5	+ 25%	21	21 POS	20	20 POS
15.0	+ 50%	21	21 POS	20	20 POS
17.5	+ 175%	21	21 POS	20	20 POS
20.0	+ 200%	21	21 POS	20	20 POS

DxC600 Analyzer		Within Run		Run to Run
Sample[, ng/mL]	% of Cutoff	# ofDetermination	Result	# ofDetermination	Result
0	- 100%	21	21 NEG	20	20 NEG
2.5	- 75%	21	21 NEG	20	20 NEG
5.0	- 50%	21	21 NEG	20	20 NEG
7.5	- 25%	21	21 NEG	20	20 NEG
10.0	100%	21	18 POS/3 NEG	20	13 POS/7 NEG
12.5	+ 25%	21	21 POS	20	20 POS
15.0	+ 50%	21	21 POS	20	20 POS
17.5	+ 175%	21	21 POS	20	20 POS
20.0	+ 200%	21	21 POS	20	20 POS

Detection Limit:

The lowest concentration that can be differentiated from the negative urine with 95% confidence is determined as 3 ng/mL on all three platforms of instruments.

Linearity:

CX4CE Ínstrument: 3-90 ng/mL LX20 Pro Instrument: 3-70 ng/mL DxC Instrument: 3-70 ng/mL

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Method comparison against GC/MS confirmation device:

CX4CE Instrument: 83 clinical unaltered samples, 93.0% agrecment with positive, 97.5% agreement with negative samples)

LX20 Pro Instrument: 82 clinical unaltered samples, 97.4% agreement with positive, 95.3% agreement with negative samples)

DxC Instrument: 83 clinical unaltered samples, 97.4% agreement with positive, 95.3% agreement with negative samples)

Specificity and Endogenous Substances:

No significant undesired cross reactants or endogenous substance interference werc observed. See product insert for list of compounds tested.

Summary:

The information provided in this pre-market notification demonstrates that the LZI Buprenorphine Enzyme Immunoassay is substantially equivalent to the legally marketed predicated device for its general intended use. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device as confirmed by gas chromatography/mass spectrometry, an independent analytical method. The information supplied in this pre-market notification provides reasonable assurance that the LZI Buprenorphine Enzyme Immunoassay is safe and effective for its stated intendcd use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. (USA)" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Lin-Zhi International, Inc. c/o Marie Lin President 687 North Pastoria Ave Sunnyvale, CA 94085

DEC 2 2 2008

Re: K081008

Trade/Device Name: Buprenorphine Enzyme Immunoassay and Norbuprenorphine Calibrators and Controls

Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, DLJ and LAS Dated: November 05, 2008 Received: November 07, 2008

Dear Ms. 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial your device 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 (240) 276-0490. 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 tolling at its tolling at its toll Inc. (800) 638-2041 or (240) 276-3150 or at its Internet address st http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., 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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Premarket Notification

Indications for Use Statement

510(k) Number (if known): K081008

Device Name: Buprenorphine Enzyme Immunoassay and Calibrators and Controls.

for Beckman Coulter® Synchron Systems

Indications For Use:

The Norbuprenorphine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay with Beckman Coulter Synchron LX®, CX®, and UniCel® DxC automated clinical system analyzers.

The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive

Prescription Use (Part 21 CFR 801 Subpart D)

Office of Evaluation and Safety Evaluation and Safety

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Office of In Vit Diagno(RerDEVCFR 801.109)
1 Gafat

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).