Liquichek Urine Toxicology Controls are intended for use as quality controls urine to monitor the performance of laboratory urine toxicology screening* procedures. *[S1E/S2E: enzyme immunoassay (EIA)]

Levels S1, S2, S3, S1 Low Opiate, and S2 Low Opiate: Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures.

Levels S1E, S2E, S1E Low Opiate and S2E Low Opiate: Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) screening procedures.

Device Description

Liquichek Urine Toxicology Controls are prepared from human urine with added drugs of abuse and metabolites of drugs of abuse, preservatives, stabilizers and constituents of animal origin. The control is provided in liquid form for convenience.

AI/ML Overview

The provided document focuses on the substantial equivalence of the "Liquichek Urine Toxicology Control (Screen Series)" device to an already marketed predicate device (K021411). The performance data presented are related to the stability of the control material rather than the diagnostic accuracy of a new testing algorithm or method.

Therefore, many of the typical questions regarding acceptance criteria and studies for diagnostic devices (like sample size, ground truth, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable in this context. This device is a control material used to monitor the performance of other urine toxicology screening procedures, not a screening procedure itself.

Here's an analysis based on the information provided, recognizing the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (related to device stability)	Reported Device Performance
Open Vial Stability: All analytes stable for 30 days when stored tightly capped at 2-8°C.	All analytes are stable for 30 days when stored tightly capped at 2-8°C.
Shelf Life (S1E, S2E, S1E Low Opiate, S2E Low Opiate): Two years stored at 2-8°C.	Two years stored at 2-8°C.
Shelf Life (S1, S2, S3, S1 Low Opiate, S2 Low Opiate): Three years stored at 2-8°C.	Three years stored at 2-8°C.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of diagnostic accuracy. The studies performed were stability studies on the control material itself. The sample size for these studies is not explicitly stated (e.g., how many vials, how many batches were tested). The provenance of the data is implied to be Bio-Rad Laboratories in Irvine, California, USA, the submitter of the device, making it prospective for the purpose of demonstrating stability.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a quality control material, not a diagnostic test that requires expert interpretation for ground truth. The "ground truth" for this device would be its certified concentrations of drugs/metabolites, which are inherently known during its manufacture.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used to resolve discrepancies in expert interpretation of diagnostic results, which is not relevant for a control material's stability study.

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. MRMC studies are for evaluating the performance of diagnostic tools (often involving human readers or AI algorithms) on patient cases. This device is a control product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a quality control material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the stability studies, the "ground truth" is the known, manufactured concentration of the analytes (drugs and metabolites) within the control material. The studies aim to demonstrate that these known concentrations remain stable over time under specified storage conditions.

8. The sample size for the training set

Not applicable. There is no training set for this type of device.

9. How the ground truth for the training set was established

Not applicable.

Summary

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K033924

Page 1 of 2

Summary of Safety and Effectiveness Liquichek Urine Toxicology Control (Screen Series)

1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1555

Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367

Date of Summary Preparation

December 16, 2003

2.0 Device Identification

Product Trade Name:

Liquichek Urine Toxicology Control (Screen Series)

0 Liquichek Urine Toxicology S1 Control
Liquichek Urine Toxicology S2 Control ப
Liquichek Urine Toxicology S3 Control 0
0 Liquichek Urine Toxicology S1 Low Opiate Control
Liquichek Urine Toxicology S2 Low Opiate Control 0
0 Liquichek Urine Toxicology S1E Control
Liquichek Urine Toxicology S2E Control
0 Liquichek Urine Toxicology S1E Low Opiate Control
0 Liquichek Urine Toxicology S2E Low Opiate Control

Common Name:	Drug Mixture Control
Classifications:	Class I
Product Code:	DIF
Regulation Number:	21 CFR 862.3280

3.0 Device to Which Substantial Equivalence is Claimed

Liquichek Urine Toxicology Control Bio-Rad Laboratories Irvine, California

Docket Number: K021411

4.0 Description of Device

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5.0 Statement of Intended Use

6.0 Comparison of the new device with the Predicate Device

The new Liquichek Urine Toxicology Controls claim substantial equivalence to the Liquichek Urine Toxicology Controls currently in commercial distribution (K021411).

Characteristics	Bio-Rad Liquichek Urine Toxicology Control(Screen Series)(New Device)	Bio-Rad Liquichek Urine Toxicology Control(Screen Series)(Predicate Device K021411)
Similarities
Intended Use	Liquichek Urine Toxicology Control is intended for useas a quality control urine to monitor the performanceof laboratory urine toxicology screening procedures.	Liquichek Urine Toxicology Control is intended for useas a quality control urine to monitor the performanceof laboratory urine toxicology screening procedures.
Form	Liquid	Liquid
Matrix	Urine	Urine
Storage(Unopened)	2-8°C until expiration date	2-8°C until expiration date
Open Vial	30 days at 2-8°C	30 days at 2-8°C
Drugs	Same as the predicate device	11-Nor-Δ-9-THC-9-COOH, Amphetamines, d-Amphetamine, Barbiturates, Benzodiazepines, Benzoylecgonine, Cannabinoids, Cocaine, Ethanol, Lysergic Acid Diethylamide (LSD), Methadone, Methaqualone, Morphine (Free), Nordiazepam, Nortriptyline, Opiates, Phencyclidine, Propoxyphene, Secobarbital, Tricyclic Antidepressants
Differences
Levels	S1, S2, S3, S1E, S2E, S1 Low Opiate and S2 LowOpiate. Includes new levels added to the productline: S1E Low Opiate and S2E Low Opiate	S1, S2, S3, S1E, S2E, S1 Low Opiate and S2 LowOpiate. Does not include levels:S1E Low Opiate and S2E Low Opiate
Preservatives &Label Warnings	Antibiotic Preservative cocktail	Contains 0.1% Sodium AzideRequires hazard symbols

Table 1. Similarities and Differences between new and predicate device.

7.0 Summary of Performance Data

Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Urine Toxicology Control (Screen Series). Product claims are as follows:

Open vial: All analytes are stable for 30 days when stored tightly capped at 2-8°C. 7.1
7.2 Shelf Life:
- ם S1E, S2E, S1E Low Opiate, S2E Low Opiate: Two years stored at 2-8 °C ם S1, S2, S3, S1 Low Opiate, S2 Low Opiate: Three years stored at 2-8 °C
7.3 Real time studies will be ongoing to support the shelf life of this product.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its body and wings. 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

FEB - 3 2004

Ms. Elizabeth Platt Regulatory Affairs Manager/Quality Assurance Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017

Re: K033924

Trade/Device Name: Liquichek Urine Toxicology Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: December 16, 2003 Received: December 18, 2003

Dear Ms. Platt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Yean 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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KO33924 510 (k) Number (if known):

Device Name:

Liquichek Urine Toxicology Control

Liquichek Urine Toxicology S1 Control 0
Liquichek Urine Toxicology S2 Control 0
Liquichek Urine Toxicology S3 Control 0
Liquichek Urine Toxicology S1 Low Opiate Control ប្រ
Liquichek Urine Toxicology S2 Low Opiate Control D
Liquichek Urine Toxicology S1E Control ロ
Liquichek Urine Toxicology S2E Control
Liquichek Urine Toxicology S1E Low Opiate Control 0
ロ Liquichek Urine Toxicology S2E Low Opiate Control

Indications for Use:

Levels S1, S2, S3, S1 Low Opiate, and S2 Low Opiate

Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures.

Levels S1E, S2E, S1E Low Opiate and S2E Low Opiate

Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) screening procedures.

Aberto Salm

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use or

Over-the Counter use

Regulation Number and Section

§ 862.3280 Clinical toxicology control material.

(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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.