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

Device Description

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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Liquichek Urine Toxicology Control (Confirmatory Series):

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria in the typical sense for a new diagnostic assay. However, we can infer the performance aspects that were considered and claimed by the manufacturer.

Performance Characteristic	Acceptance Criteria (Implicit/Claimed)	Reported Device Performance
Intended Use	To monitor the performance of laboratory urine toxicology confirmatory procedures.	Device is intended for this use, matching the predicate.
Form	Liquid	Liquid form, matching the predicate.
Matrix	Urine	Urine matrix, matching the predicate.
Storage (Unopened)	Stable until expiration date at 2 to 8°C.	3 Years at 2 to 8°C (Shelf Life).
Open Vial Stability	All analytes stable for 30 days when stored tightly capped at 2 to 8°C.	30 days at 2 to 8°C.
Analytes Present	Must contain specific drugs of abuse and metabolites, including the newly added MDMA, MDA, and MDEA (in C2, C3, C4).	Contains all listed analytes, including the new MDMA, MDA, and MDEA.
Comparability	Similar to the predicate device in intended use, form, matrix, and storage conditions, with the specified addition of new analytes.	Demonstrated similarity to predicate device (K021384).

Note: The document does not provide specific quantitative acceptance limits (e.g., +/- 10% from target concentration) for the control's performance when monitoring confirmatory procedures. The substantiation focuses on the stability and formulation of the control material itself.

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

Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of device performance data (e.g., clinical samples). The studies performed relate to the stability of the control material, not its performance against patient samples.
Data Provenance: The document states "All supporting data is retained on file at Bio-Rad Laboratories." There is no mention of country of origin or whether the data is retrospective or prospective, though stability studies are generally prospective by nature.

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

This information is not applicable to the provided document. The device is a quality control material, not a diagnostic device that interprets patient data. Therefore, there is no "ground truth" established by experts in the context of patient diagnosis. The "ground truth" for this device would be the accurately known concentrations of the analytes within the control material, which is established during its manufacturing and characterization process by the manufacturer (Bio-Rad Laboratories).

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. There is no expert adjudication for a quality control material.

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:

This information is not applicable. The device is a quality control material, not an AI-powered diagnostic tool, and it does not involve human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. The device is a physical quality control material, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device is the known, established concentrations of the specific drug analytes and their metabolites within the control material. This is determined through the manufacturing and analytical characterization processes of Bio-Rad Laboratories.

8. The Sample Size for the Training Set:

This information is not applicable. As a quality control material, there is no "training set" in the context of machine learning or diagnostic algorithm development.

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

This information is not applicable for the same reasons as point 8. The "ground truth" for the control material is inherent to its formulation and analytical characterization.

Summary

{0}------------------------------------------------

DEC 12 2003

K033404

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

1.0 Submitter

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

Contact Person

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

Date of Summary Preparation

October 22, 2003

2.0 Device Identification

Product Trade Name:

Liquichek Urine Toxicology Control

Liquichek Urine Toxicology Control Level C1 ם
Liquichek Urine Toxicology Control Level C2 0
Liquichek Urine Toxicology Control Level C3
Liquichek Urine Toxicology Control Level C4 0
Liquichek Urine Toxicology Control Level C2 Low Opiate ם
Liquichek Urine Toxicology Control Level C3 Low Opiate ට

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

Device to Which Substantial Equivalence is Claimed 3.0

Liquichek Urine Toxicology Control Levels C1, C2, C3 and C4 Bio-Rad Laboratories Irvine, California Docket Number: K021384

Description of Device 4.0

Statement of Intended Use 5.0

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

{1}------------------------------------------------

Comparison of the new device with the Predicate Device 6.0

Control contains 3.4-Methylenedioxy-Toxicology Liquichek Urine The new methamphetamine (MDMA), 3,4-Methylenedioxyamphetamine (MDA) and 3.4methylenedioxy-N-ethylamphetamine (MDEA) in levels C2, C3 and C4 , and the Mich our entry to Liquichek Urine Toxicology Control (K021384) to which substantial equivalence is claimed does not contain these analytes.

Characteristics	Bio-Rad Liquichek Urine Toxicology Control(Confirmatory Series)(New Device)	Bio-Rad Liquichek Urine Toxicology ControlLevels C1, C2, C3 and C4(Predicate Device K021384)
Similarities
Intended Use	Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.	Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.
Form	Liquid	Liquid
Matrix	Urine	Urine
Storage (Unopened)	2 to 8°C until expiration date	2 to 8°C until expiration date
Open Vial	30 days at 2 to 8°C	30 days at 2 to 8°C
Differences
Drugs	Same as the predicate device with the addition in Levels C2, C3 and C4 of:3,4-Methylenedioxymethamphetamine (MDMA),3,4-Methylenedioxyamphetamine (MDA) and3,4-Methylenedioxy-N-ethylamphetamine (MDEA)	11-Nor-Δ-9-THC-9-COOH, Alpha-Hydroxyalprazolam,Amobarbital, d-Amphetamine, Benzoylecgonine,Butalbital, Codeine, Ethanol, Lysergic AcidDiethylamide (LSD), d-Methamphetamine,Methadone, Methaqualone, Morphine-3-β-D-Glucuronide, Nordiazepam, Norpropoxyphene,Pentobarbital, Phencyclidine, Phenobarbital,SecobarbitalDoes not contain:3,4-Methylenedioxymethamphetamine (MDMA),3,4-Methylenedioxyamphetamine (MDA) and3,4-Methylenedioxy-N-ethylamphetamine (MDEA)
Label Warnings	Does not require hazard symbols	Requires hazard symbols

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

7.0 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:

Open vial: All analytes will be stable for 30 days when stored tightly capped at 2 to 8°C. 7.1
Shelf Life: 3 Years at 2 to 8°C 7.2
Real time studies will be ongoing to support the shelf life of this product. 7.3

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

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Maria Zeballos, RAC Regulatory Affairs Specialist Bio-Rad Laboratories, QSD Diagnostics Group 9500 Jeronimo Road Irvine, CA 92618-2017

Re: K033404

Trade/Device Name: Liquichek Urine Toxicology Control Level C1 Liquichek Urine Toxicology Control Level C2 Liquichek Urine Toxicology Control Level C3 Liquichek Urine Toxicology Control Level C4 Liquichek Urine Toxicology Control Level C2 Low Opiate Liquichek Urine Toxicology Control Level C3 Low Opiate Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: October 22, 2003 Received: October 29, 2003

DEC 1 2 2003

Dear Ms. Zeballos:

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).

{3}------------------------------------------------

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,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510 (k) Number (if known): K033 404

Device Name:

Liquichek Urine Toxicology Confirmatory Series Control

Liquichek Urine Toxicology Control Level C1 ロ
Liquichek Urine Toxicology Control Level C2 0
Liquichek Urine Toxicology Control Level C3 0
Liquichek Urine Toxicology Control Level C4 D
Liquichek Urine Toxicology Control Level C2 Low Opiate 0
Liquichek Urine Toxicology Control Level C3 Low Opiate ப

Indications for Use:

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

(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

Albert
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033404

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.