Liquichek™ Urine Toxicology Control Levels S1E and S2E 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 Control Levels S1E and S2E is prepared from human urine with added constituents of animal origin, drugs, drug metabolites, preservatives, and stabilizers. The control is provided in liquid form for convenience.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called Liquichek™ Urine Toxicology Control Levels S1E and S2E. This device is a quality control material, not an AI/ML-driven diagnostic device or an imaging device. Therefore, the questions related to AI performance metrics (like sample size for test set, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance, training set size, and training set ground truth) are not applicable to this type of product.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device by comparing characteristics and providing stability data.

Here's an attempt to answer the relevant parts, interpreting "acceptance criteria" as the product's claimed performance specifications:

1. Acceptance Criteria and Reported Device Performance

For a quality control material, "acceptance criteria" primarily relate to its stability and its ability to function as intended to monitor laboratory performance. The document details two key performance criteria for the new device (Liquichek™ Urine Toxicology Control Levels S1E and S2E) related to stability:

Acceptance Criteria	Reported Device Performance
Open Vial Stability	All analytes stable for 30 days when stored tightly capped at 2-8°C.
Shelf Life (Unopened)	2 years when stored unopened at 2-8°C.

Study Proving Acceptance Criteria:

The document states: "Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Urine Toxicology Control." It also mentions: "Real time studies will be ongoing to support the shelf life of this product."

Study Type: Stability studies (both open-vial and shelf-life).
Methodology: The document does not provide details on the specific methodology of these stability studies (e.g., number of batches tested, frequency of testing, analytical methods used for verification). It only states that the studies were performed and that supporting data is retained on file at Bio-Rad Laboratories.
Result: The studies supported the claims of 30-day open-vial stability and a 2-year shelf life.

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

Not Applicable: This product is a quality control material, not an AI/ML diagnostic. The concept of a "test set" in the context of diagnostic accuracy for AI models does not apply here. The document describes stability studies, but doesn't detail their sample size or provenance beyond stating they were performed by Bio-Rad Laboratories.

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 is a quality control material, not an AI/ML diagnostic or imaging device requiring expert ground truth for a test set.

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

Not Applicable: This is a quality control material, not an AI/ML diagnostic or imaging device requiring adjudication for a test set.

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 a quality control material, not an AI/ML diagnostic that would be subject to MRMC studies.

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

Not Applicable: This is a quality control material, not an AI/ML algorithm.

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

Not Applicable: For this quality control material, "ground truth" would refer to the assigned concentrations of the analytes within the control, which are established during manufacturing based on precise spiking and analytical methods, not through expert consensus, pathology, or outcomes data in the traditional sense for a diagnostic device.

8. The sample size for the training set

Not Applicable: This is a quality control material, not an AI/ML model that undergoes "training."

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

Not Applicable: This is a quality control material, not an AI/ML model for which a training set's ground truth needs to be established.

Summary

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K022767

Summary of Safety and Effectiveness Liquichek™ Urine Toxicology Control Levels S1E and S2E

1.0 Submitter

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

Contact Person

Elizabeth Platt RA/QA Manager Telephone: (949) 598-1285

Date of Summary Preparation

August 2, 2002

2.0 Device Identification

Product Trade Name:	Liquichek™ Urine Toxicology Control Levels S1E andS2E
Common Name:	Drug Mixture Controls
Classifications:	Class I
Product Code:	91DIF
Regulation Number:	CFR 862.3280

3.0 Device to Which Substantial Equivalence is Claimed

Liquichek 1M Urine Toxicology Control Levels S1 and S2 Bio-Rad Laboratories Irvine, California

Docket Numbers: K991558

4.0 Description of Device

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Statement of Intended Use 5.0

ﺮ ﺍﻟﻤﺮﺍﺟﻊ

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.

6.0 Comparison of the new device with the Predicate Device

The new Liquichek™ Urine Toxicology Control claims substantial equivalence to the Liquichek™ Urine Toxicology Controls currently in commercial distribution (K991558).

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

Characteristics	Bio RadLiquichek™ Urine Toxicology Control,Levels S1E and S2E(New Device)	Bio RadLiquichek™ Urine Toxicology Control,Levels S1 ans S2(Predicate Device)
Similarities
Form	Liquid	Liquid
Matrix	Human urine	Human urine
Storage(Unopened)	2-8° Cuntil expiration date	2-8° Cuntil expiration date
Open VialClaim	2-8° C for 30 days	2-8° C for 30 days
Differences
Intended Use	A quality control urine to monitor theperformance of laboratory urinetoxicology enzyme immunoassay(EIA) screening procedures.	A quality control urine to monitor theperformance of laboratory urinetoxicology screening procedures.
Levels	Level S1E = Drugs and drugmetabolites added duringmanufacture at concentrations20-25% below enzymeimmunoassay cutoff levels.Level S2E = Drugs and drugmetabolites added at concentrations20-25% above enzymeimmunoassay cutoff levels.	Level S1 = Drugs and drugmetabolites added at concentrations20-25% below immunoassay cutofflevels.Level S2 = Drugs and drugmetabolites added at concentrations20-25% above immunoassay cutofflevels.

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Characteristics	Bio RadLiquichek™ Urine Toxicology Control,Levels S1E and S2E(New Device)	Bio RadLiquichek™ Urine Toxicology Control,Levels S1 and S2(Predicate Device)
Differences
ClaimedAnalytes	Methamphetamine, Secobarbital,Lormetazepam, Tetrahydrocannabinol(THC), Benzoylecgonine, Ethanol,Lysergic Acid Diethylamide (LSD),Methadone, Methaqualone, Morphine(Free), Phencyclidine, Propoxyphene,Nortriptyline and addition of Creatinine,pH, Specific Gravity.	Amphetamine, Secobarbital,Nordiazepam, Tetrahydrocannabinol(THC), Benzoylecgonine, Ethanol,Lysergic Acid Diethylamide (LSD),Methadone, Methaqualone, Morphine(Free), Phencyclidine, Propoxyphene,Nortriptyline.

2.0 STATEMENT OF SUPPORTING DATA

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

2.1 Open vial: Once the control is opened, all analytes will be stable for 30 days when stored tightly capped at 2-8°C.
2.2 Shelf Life: 2 years when stored unopened at 2-8°C.

Real time studies will be ongoing to support the shelf life of this product.

All supporting data is retained on file at Bio-Rad Laboratories.

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Image /page/3/Picture/1 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 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.

AUG 2 2 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K022707

Trade/Device Name: Liquichek™ Urine Toxicology Control Levels S1E and S2E Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: August 2, 2002 Received: August 14, 2002

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. Iisting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________

Device Name: Liquichek™ Urine Toxicology Control Levels S1E and S2E

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription use Over-the Counter or use

Carol C. Benson (for Jean Cooper, DUm

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.