Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard enzyme immunoassay method for detecting a drug metabolite. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis is based on direct chemical reactions and spectrophotometric measurements, not algorithmic learning or pattern recognition.

Therapeutic

No.
The device is intended for the qualitative and semi-quantitative determination of a buprenorphine metabolite in human urine, used for diagnostic purposes (drug testing), not for treating a disease or condition.

Diagnostic

Yes

The device is intended for the "qualitative and semi-quantitative determination of norbuprenorphine (buprenorphine metabolite) in human urine," which is a measurement used in diagnosing and monitoring drug use. Furthermore, it is explicitly mentioned that "A more specific alternative chemical method must be used in order to obtain a confirmed analytical result," suggesting its role as a preliminary diagnostic tool.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a homogeneous enzyme immunoassay with ready-to-use liquid reagents and relies on automated clinical system analyzers (Beckman Coulter® Synchron LX®, CX®, and UniCel® DxC) to measure absorbance changes. This involves physical reagents and hardware components, not just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's for the "qualitative and semi-quantitative determination of norbuprenorphine (buprenorphine metabolite) in human urine." This involves testing a sample taken from the human body in vitro (outside the body) to provide information about a physiological state (presence of a drug metabolite).
Device Description: The description details a "homogeneous enzyme immunoassay" that measures enzyme activity in a sample. This is a common technique used in IVD tests.
Performance Studies: The performance studies describe testing the device with "clinical unaltered samples" and comparing results to a "GC/MS confirmation device." This demonstrates the device is intended for use with human samples in a clinical context.
Predicate Device: The mention of a "Predicate Device" with a K number (K040316) indicates that this device has gone through a regulatory process (likely 510(k) clearance in the US) for IVD devices.

Therefore, all the provided information points to this device being an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 UniCcl® 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.

Product codes

DJG, DLJ, LAS

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Human urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

Summary of Performance Studies

Precision: Semi-Quantitative, ng/mL

CX4CE Analyzer: Within-Run (n=21), Run-to-Run (n=20 over 2 weeks) for sample concentrations from 0 to 20.0 ng/mL.
LX20 Pro Analyzer: Within-Run (n=21), Run-to-Run (n=20 over 2 weeks) for sample concentrations from 0 to 20.0 ng/mL.
DxC600 Analyzer: Within-Run (n=21), Run-to-Run (n=20 over 2 weeks) for sample concentrations from 0 to 20.0 ng/mL.

Precision: Qualitative, mA/min

CX4CE Analyzer: Within-Run (n=21), Run-to-Run (n=20 over 2 weeks) for sample concentrations from 0 to 20.0 ng/mL.
LX20 Pro Analyzer: Within-Run (n=21), Run-to-Run (n=20 over 2 weeks) for sample concentrations from 0 to 20.0 ng/mL.
DxC600 Analyzer: Within-Run (n=21), Run-to-Run (n=20 over 2 weeks) for sample concentrations from 0 to 20.0 ng/mL.

Precision: Qualitative, Positive/Negative at cutoff 10 ng/mL

CX4CE Analyzer: Within Run (n=21), Run to Run (n=20)
- 10.0 ng/mL (100% of Cutoff): 13 POS/8 NEG (Within Run), 12 POS/8 NEG (Run to Run)
- 12.5 ng/mL (+25%): 21 POS (Within Run), 20 POS (Run to Run)
LX20 Pro Analyzer: Within Run (n=21), Run to Run (n=20)
- 10.0 ng/mL (100% of Cutoff): 21 POS (Within Run), 20 POS (Run to Run)
- 12.5 ng/mL (+25%): 21 POS (Within Run), 20 POS (Run to Run)
DxC600 Analyzer: Within Run (n=21), Run to Run (n=20)
- 10.0 ng/mL (100% of Cutoff): 18 POS/3 NEG (Within Run), 13 POS/7 NEG (Run to Run)
- 12.5 ng/mL (+25%): 21 POS (Within Run), 20 POS (Run to Run)

Detection Limit:

3 ng/mL on all three platforms of instruments.

Linearity:

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

Method comparison against GC/MS confirmation device:

CX4CE Instrument: 83 clinical unaltered samples, 93.0% agreement 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not explicitly stated as Sensitivity, Specificity, PPV, NPV, but agreement percentages with GC/MS are provided:

CX4CE Instrument: 93.0% agreement with positive, 97.5% agreement with negative samples.
LX20 Pro Instrument: 97.4% agreement with positive, 95.3% agreement with negative samples.
DxC Instrument: 97.4% agreement with positive, 95.3% agreement with negative samples.

Predicate Device(s)

K040316

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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, Opiates
Class II, DJG (91 Toxicology),
21 CFR 862.3650

Norbuprenorphine calibrators,
Class II, DLJ (91 Toxicology),
21 CFR 862.3200

Norbuprenorphine controls,
Class I, LAS (91 Toxicology),
21 CFR 862.3280 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Homogeneous Buprenorphine Enzyme Immunoassay |
| Proprietary Name: | LZI Buprenorphine Enzyme Immunoassay, Calibrators and
Controls: for Beckman Coulter® Synchron Systems |

1

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

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

Intended Use

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 UniCcl® 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.

2

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.

| Device

Characteristics	Subject Device	Predicate Device
	LZI Buprenorphine Enzyme
Immunoassay	CEDIA® Buprenorphine Assay
(K040316)
	for Beckman Coulter® Synchron Systems
Intended Use	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.

This assay provides a rapid screening procedure
for determining the presence of norbuprenorphine
(buprenorphine metabolite) in urine. 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. | The CEDIA Buprenorphine assay is a
homogeneous enzyme immunoassay for
qualitative or semi-quantitative
determination of the presence of
buprenorphine in human urine at cutoff
concentration of 5 ng/mL. The assay
provides a simple and rapid analytical
screening procedure to detect
buprenorphine in human urine.

3

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

CX4CE Analyzer:

| Drug:
Norbuprenorphine | Sample
concentration,
ng/mL
Within-Run
(n=21) | Mean,
ng/mL | SD | CV% | | Mean,
ng/mL
Run-to-Run
(n=20 over 2
weeks) | 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 | 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 | 0.0 | 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 |

4

Precision: Qualitative, mA/min

CX4CE Analyzer:

| Drug:
Norbuprenorphine | Sample
concentration,
ng/mL | Mean,
mA/min | SD | CV% | | Mean,
mA/min | SD | CV% |
|---------------------------|-----------------------------------|-----------------|-----|-----|--------------------------------------|-----------------|-----|-----|
| | Within-Run
(n=21) | | | | Run-to-Run
(n=20 over 2
weeks) | | | |
| 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 | Sample
concentration,
ng/mL | Within-Run
(n=21) | | | Run-to-Run
(n=20 over 2
weeks) | | |
|---------------------------|-----------------------------------|----------------------|-----|-----|--------------------------------------|-----|-----|
| | | 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: | Sample
concentration,
ng/mL | Mean,
mA/min | SD | CV% | | Mean,
mA/min | SD | CV% |
|------------------|-----------------------------------|-----------------|-----|-----|--------------------------------------|-----------------|-----|-----|
| Norbuprenorphine | Within-Run
(n=21) | | | | Run-to-Run
(n=20 over 2
weeks) | | | |
| 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 |

5

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	# of
Determination	Result	# of
Determination	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	# of
Determination	Result	# of
Determination	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

6

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.

7

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 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 urinc, 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). 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)
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