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

Device Description

Liguichek 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 text is for a 510(k) premarket notification for a medical device (Liquichek Urine Toxicology Control). A 510(k) submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies to prove performance against specific acceptance criteria.

Therefore, many of the requested elements (e.g., sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable or not present in this type of regulatory document. This document is a Summary of Safety and Effectiveness, which details the device, its intended use, and how it compares to a legally marketed predicate device. The "Statement of Supporting Data" section primarily addresses stability studies for the control material itself, not the performance of an AI-driven diagnostic device.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not specify "acceptance criteria" in the sense of performance thresholds for an AI or diagnostic algorithm (e.g., sensitivity, specificity). Instead, it describes claims related to the stability of the control material. The "reported device performance" in this context refers to the validated stability periods.

Acceptance Criteria (Implied from Claims)	Reported Device Performance (Stability)
Open Vial Stability: 30 days at 2°C to 8°C	30 days at 2°C to 8°C
Closed Vial (Thawed) Stability: 45 days at 2°C to 8°C	45 days at 2°C to 8°C
Shelf Life Stability: 2 Years at -20°C to -70°C	2 Years at -20°C to -70°C

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 / Not provided. This document does not describe a "test set" for evaluating a diagnostic algorithm. The studies mentioned are stability studies for a quality control material.

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 / Not provided. This is a quality control material, not a diagnostic device requiring expert interpretation for ground truth.

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

Not applicable / Not provided.

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

No, an MRMC study was not done. This device is a quality control material, not an AI-assisted diagnostic tool.

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

Not applicable / Not provided. This device is a quality control material, not a standalone diagnostic algorithm.

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

For the stability studies, the "ground truth" would be established by analytical testing using validated methods (e.g., mass spectrometry, immunoassays) to confirm the concentration and integrity of the analytes within the control material over time and under different storage conditions. The document doesn't detail the specific analytical methods, but these are standard lab practices for control materials.

8. The sample size for the training set

Not applicable / Not provided. There is no "training set" as this is not an AI/ML device.

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

Not applicable / Not provided.

Summary

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

Summary of Safety and Effectiveness Liquichek Urine Toxicology Control

MAR 2 7 2012

1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1557 Fax:

Contact Person

Suzanne Parsons Regulatory Affairs Manager Telephone: (949) 598-1467

Date of Summary Preparation

February 16th, 2012

·2.0 Device Identification

Product Trade Name:

Liquichek Urine Toxicology Control

Liquichek Urine Toxicology Control Level S10

Liquichek Urine Toxicology Control Level S20
Liquichek Urine Toxicology Control Level S10 Low Opiate
Liquichek Urine Toxicology Control Level S2O Low Opiate

Common Name:	Drug Mixture Control Materials
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 (Screen Series) Bio-Rad Laboratories Irvine, California

510 (k) Number: K033924

4.0 Description of Device

5.0 Intended Use

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

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

Comparison of the new device with the Predicate Device 6.0

Liquichek Urine Toxicology Control claims substantial equivalence to the Liquichek Urine Toxicology Control (Screen Series) currently in commercial distribution (K033924). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.

Characteristics	Liquichek Urine Toxicology Control(New Device)	Liquichek Urine Toxicology Control(Screen Series)(Predicate Device, K033924)
	Similarities
Intended Use	Liquichek Urine Toxicology Control isintended for use as a quality control urineto monitor the precision oflaboratory urine toxicology screeningprocedures.	Liquichek Urine Toxicology Control isintended for use as a quality control urineto monitor the performance of laboratoryurine toxicology screening procedures.
Matrix	Human Urine	Human Urine
Form	Liquid	Liquid
Open Vial Stability	30 days at 2°C to 8 °C	30 days at 2°C to 8 °C

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

	Differences
Storage unopened (Shelf Life)	-20 to -70°C until expiration date	2 to 8°C until expiration date
Closed Vial (Thawed) Stability	45 days at 2°C to 8 °C	No Claim
Levels	Level S1O, S2O, S1O Low Opiate, S2OLow Opiate	Levels S1, S2, S3, S1 Low Opiate andS2 Low Opiate
Analytes	Contains:11-Nor-Δ-9-THC-9-COOHBenzoylecgonineEthanolLysergic Acid Diethylamide (LSD)MethadoneMethaqualoneMorphine (Free)OxazepamPhencyclidine (PCP)PropoxypheneSecobarbitald-MethamphetamineDoes not contain:NordiazepamNortriptylined-Amphetamine	Contains:11-Nor-Δ-9-THC-9-COOHBenzoylecgonineEthanolLysergic Acid Diethylamide (LSD)MethadoneMethaqualoneMorphine (Free)NordiazepamNortriptylinePhencyclidine (PCP)PropoxypheneSecobarbitald-AmphetamineDoes not contain:d-MethamphetamineOxazepam

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

7.0 Statement of Supporting Data

Stability studies have been performed for Liquichek Urine Toxicology control to determine Stabliky otation have belf life claims. Product claims. Product claims are as follows:

	7.1 Open Vial:	30 days at 2 to 8°C.
	7.2 Closed Vial (Thawed):	45 days at 2 to 8°C.
	7.3 Shelf Life Stability	2 Years at -20°C to -70°C

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

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

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

MAR 2 7 2012

K120504 Re:

Trade/Device Name: Liquichek Urine Toxicology Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I (Reserved) Product Code: DIF Dated: February 17, 2012 Received: February 21, 2012

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).

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.

Image /page/3/Picture/13 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, with three abstract shapes representing the head, body, and legs. The figure is positioned to the right of the department's name, which is written in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

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

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use Form

510(k) Number (if known):

Device Name:

Liquichek Urine Toxicology Control

· Liquichek Urine Toxicology Control Level S10
Liquichek Urine Toxicology Control Level S2O
Liquichek Urine Toxicology Control Level S10 Low Opiate .
Liquichek Urine Toxicology Contro! Level S2O Low Opiate .

Indications for Use:

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

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

ﺗ

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(K) K120504

Page 1 of

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.