The Multiple Analyte (Benzoylecgonine, Methamphetamine, Methadone, Morphine. Oxazepam, Secobarbital, Phencyclidine, and Propoxyphene) Urine Drugs of Abuse Calibrators intended for in vitro diagnostic use for the calibration of their respective enzyme immunoassays to detect d-methamphetamine, benzoylecgonine, opiate, benzodiazepines. barbiturates, methadone, phencyclidine or propoxyphene in human urine.

The Multiple Analyte (Benzoylecgonine, Methamphetamine, Methadone, Morphine, Oxazepam, Secobarbital, Phencyclidine, and Propoxyphene) Urine Drugs of Abuse Controls are intended for in vitro diagnostic use for the validation of their respective enzyme immunoassays to detect d-methamphetamine, benzoylecgonine, opiate, benzodiazepines, barbiturates, methadone, phencyclidine or propoxyphene in human urine.

Device Description

All of the DAU Calibrators and Controls are 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 as a mixture.

The Negative DAU Calibrator is a processed, drug-free human urine matrix. The Low, Cutoff. Intermediate, and High Calibrators, as well as the 2 levels of Controls are prepared by spiking known concentrations of drug analyte into the Negative DAU Calibrator matrix. The various concentrations of each drug analyte in their corresponding calibrators and controls are summarized as follows:

	LowCalibrator	CutoffCalibrator	IntermediateCalibrator	HighCalibrator	ControlLevel 1	ControlLevel 2
Material	ng/mL	ng/mL	ng/mL	ng/mL	ng/mL	ng/mL
Methamphetamine	250	500	750	1000	375	625
Secobarbital	100	200	500	1000	100	300
Oxazepam	100	200	500	1000	100	300
Benzoylecgonine	75	150	300	1000	110	190
Methadone	150	300	600	1000	225	375
Morphine	1000	2000	4000	6000	1500	2500
Phencyclidine	12.5	25	50	100	18	35
Propoxyphene	150	300	600	1000	225	375

AI/ML Overview

The provided 510(k) summary (K051088) describes Lin-Zhi International, Inc.'s Multiple Analyte Urine Drugs of Abuse Calibrators and Controls. This device is a set of liquid calibrators and controls used for in vitro diagnostic testing to detect various drugs of abuse in human urine via enzyme immunoassays.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria, but it implies that the performance characteristics were deemed "acceptable" based on established guidelines. The device's performance is tied to its manufacturing process and confirmation against GC/MS.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Precision	Not explicitly stated, but "acceptable" for intended use.	"acceptable"
Accuracy	Confirmed with GC/MS.	"acceptable"
Stability	Not explicitly stated, but "acceptable" for intended use.	"acceptable"
Matrix	Processed, drug-free human urine matrix similar to predicate.	Processed, drug-free human urine matrix.
Intended Use	Calibration/Validation of enzyme immunoassays for drugs of abuse in human urine.	Matches intended use.
Preparation	According to SAMHSA's guidelines.	According to SAMHSA's guidelines.
Concentrations	Spiked known concentrations confirmed by GC/MS.	Confirmed by GC/MS.

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

The document does not specify a distinct "test set" in the context of an AI/algorithm-based device. Instead, the testing pertains to the quality control and validation of the calibrator and control materials themselves.

Sample Size:
- The sample size for confirming the concentrations of the calibrators and controls is not explicitly stated. It refers to the "spiked values of calibrators and controls" being confirmed. This would likely involve multiple aliquots or batches of each calibrator and control level.
Data Provenance:
- The calibrators and controls are prepared by spiking known concentrations of drug analyte into a "processed, drug-free human urine matrix."
- The document does not specify the country of origin for this human urine matrix.
- The data is inherently prospective in the sense that the device itself is manufactured, and its characteristics (concentration, accuracy) are assessed.

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

The concept of "experts" establishing ground truth in the traditional sense of image interpretation or clinical diagnosis is not directly applicable here.

Ground Truth Establishment: The "ground truth" for the concentrations of drug analytes in the calibrators and controls is established by:
- "Spiking known concentrations of drug analyte" into the urine matrix. This implies precise laboratory measurements and preparation.
- Confirmation with GC/MS (Gas Chromatography/Mass Spectrometry): GC/MS is a highly accurate analytical method often considered a gold standard for confirming the presence and concentration of substances in toxicology. This is an objective chemical measurement, not an expert opinion.
Qualifications of Experts: Not applicable in the context of expert human review. The expertise lies in analytical chemistry and laboratory practice for GC/MS analysis and solution preparation.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used for disagreements in human expert interpretations in clinical studies. This is not relevant for the type of device and testing described. The "adjudication" for the concentrations is performed by a comparison against GC/MS results, which is a definitive analytical method used for confirmation.

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

No MRMC study was performed or is applicable here. This device is a laboratory reagent (calibrator/control) and not an AI or imaging device that would assist human readers in interpretation. Therefore, there is no "effect size of how much human readers improve with AI vs without AI assistance."

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical chemical product (calibrator/control), not an algorithm or software. It does not have an "algorithm-only" performance in the sense of AI. Its performance is evaluated by its ability to accurately reflect known concentrations when measured by standard analytical methods.

7. Type of Ground Truth Used

The ground truth used for the device's performance is analytical (objective chemical measurement). Specifically:

Spiked Concentrations: The concentrations of the drug analytes are known because they are accurately spiked into the matrix during manufacturing.
GC/MS Confirmation: These known, spiked concentrations are then confirmed using Gas Chromatography/Mass Spectrometry, which acts as the definitive analytical ground truth.

8. Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning model, so there is no "training set" in that context. The "training" for the device would be the quality control and manufacturing processes ensuring consistency.

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

Not applicable, as there is no "training set" for an AI model. For the manufacturing of the calibrators and controls, the "ground truth" for the raw materials and spiking concentrations is established through:

Certified Reference Materials: Use of accurately weighed and certified pure drug analytes.
Precision Laboratory Techniques: Accurate volumetric and gravimetric measurements during spiking.
Quality Control Processes: In-process checks and final product testing to ensure batch-to-batch consistency and accuracy against the intended formulations.

Summary

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K051088

JUN 2 4 2005

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is heing 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 Pastroia 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:	Drug Mixture Calibrator MaterialsClass II, DKB (91 Toxicology), 21 CFR862.3200
Common/Usual Name:	Benzoylecgonine, Methamphetamine, Methadone, Morphine,Oxazepam, Secobarbital, Phencyclidine, PropoxypheneCalibrators
Proprietary Name:	None
(B) Classification Name:	Drug Mixture Control Materials;Class I, DIF (91 Toxicology), 21 CFR 862.3280
Common/Usual Name:	Benzoylecgonine, Methamphetamine, Methadone, Morphine.Oxazepam, Secobarbital, Phencyclidine, PropoxypheneControls
Proprietary Name:	None

Legally Marketed Predicate Device(s)

Lin-Zhi International, Inc.'s Multiple Analyte Urine Drugs of Abuse Calibrators and Controls are prepared according to the SAMHSA's guideline and confirmed with GC/MS. Lin-Zhi International, Inc.' Multiple Analyte Urine Drugs of Abuse Calibrators and Controls are substantially equivalent to the Drugs of Abuse Urine Calibrators and Controls (Dade Behring, Microgenics), cleared under premarket notification K993755 (Dade Behring), K983159 (DRI, now Microgenics).

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Device Description

	LowCalibrator	CutoffCalibrator	IntermediateCalibrator	HighCalibrator	ControlLevel 1	ControlLevel 2
Material	ng/mL	ng/mL	ng/mL	ng/mL	ng/mL	ng/mL
Methamphetamine	250	500	750	1000	375	625
Secobarbital	100	200	500	1000	100	300
Oxazepam	100	200	500	1000	100	300
Benzoylecgonine	75	150	300	1000	110	190
Methadone	150	300	600	1000	225	375
Morphine	1000	2000	4000	6000	1500	2500
Phencyclidine	12.5	25	50	100	18	35
Propoxyphene	150	300	600	1000	225	375

Multiple Analyte Calibrators and Controls:

Intended Use

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Comparison to Predicate Device

LZI's Multiple Analyte urine DAU Calibrators and Controls are prepared according to the SAMHSA published guidelines. They are similar in intended use, matrix, and performance to the Microgenics's Drugs of Abuse Urine Calibrators and Controls, and Dade Behring Multianslyte Calibrators and Controls.

all spiked values of calibrators and controls were confirmed with GC/MS. Performance characteristics on precision, accuracy and stability are acceptable.

Conclusion

The information provided in the premarket notification demonstrates that the LZI's urine Multi-Analyte Drugs of Abuse Calibrators and Controls are safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

JUN 2 4 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K051088 Re:

K051000
Trade/Device Name: Multiple Analyte Urine Calibrators and Controls Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DKB, DIF Dated: April 26, 2005 Received: April 28, 2005

Dear Dr. Lin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premium is substantially equivalent (for the indications felerenced above and nave acterimined by marketed predicate devices marketed in interstate for use stated in the encrosule) to tegans actment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Forley of Dr commerce prior to May 20, 1970, the excordance with the provisions of the Federal Food, Drug, devices mat have been rechasified in asse e approval of a premarket approval application (PMA). and Costinetic Act (11ct) that do not request to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the rice labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (500 acove) inrols. Existing major regulations affecting your device it may be subject to such additions comes of the result to 895. In addition, FDA can be found in This 21, Occaments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dri- 5 issuance or a cadevice complies with other requirements of the Act that IDA has made a acternations administered by other Federal agencies. You must br any I cochar statutes and regulations, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice erequirements 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) I ms icter will anow you to organ maing of substantial equivalence of your device to a legally premarket notification: "The PDs 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, r you destre specific inte motion and advertising of your device, please contact the Office of In of quostions on the promotion and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tou may obtain other general information on your responsibilities under the Act from the Tou may other general mistmannianal 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/industry/support/index.html.

Sincerely yours,

Carol C. Benam

Carol C. Benson, M.A. Acting 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): _ KOS 1088

Device Name: Multiple Analyte Urine Calibrators and Controls

Indications for Use:

The Multiple Analyte (Benzoylecgonine, Methamphetamine, Methadone, Morphine, Oxazepam, Secobarbital, Phencyclidine, and Propoxyphene) Urine Drugs of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of their respective enzyme immunoassays to detect d-methamphetamine, benzoylecgonine, opiate, benzodiazepines, barbiturates, methadone, phencyclidine or propoxyphene in human urine.

(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K051688

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

§ 862.3200 Clinical toxicology calibrator.

(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). 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.