Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Description

Liquichek Urine Chemistry Control is prepared from human urine with added constituents of human and animal origin, chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Bio-Rad Laboratories Liquichek Urine Chemistry Control. This document is for a quality control material, not a diagnostic device with complex performance criteria or AI components. Therefore, many of the requested elements for a diagnostic device performance study (e.g., sample size for test sets, data provenance, ground truth establishment, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of submission.

Here is an analysis based on the information provided, highlighting the applicable criteria and findings for this specific type of device (a quality control material):

1. Table of Acceptance Criteria and Reported Device Performance

For this quality control material, the "acceptance criteria" are related to its stability and its comparability to a predicate device for its intended use. The "reported device performance" demonstrates it meets these criteria.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Intended Use Equivalence	To be used as an assayed quality control urine to monitor the precision of laboratory testing procedures for listed analytes.	The new device has the same intended use as the predicate device (K020817).
Matrix Equivalence	Human urine matrix.	The new device is prepared from human urine, matching the predicate.
Form Equivalence	Liquid form.	The new device is in liquid form, matching the predicate.
Open Vial Stability	30 days at 2°C to 8°C.	Stability studies confirmed 30 days at 2°C to 8°C.
Shelf Life Stability	2°C to 8°C until expiration date (24 months).	Stability studies confirmed 24 Months at 2°C to 8°C.
Performance Similarity	Performs similarly to the predicate device.	The submission states "performs similarly as the predicate device" based on value assignment derived from replicate analyses by the manufacturer and/or independent laboratories. (Specific quantitative comparison data is not provided in this summary but is implied to be on file).

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a diagnostic device. For quality control materials, "testing" involves stability studies and value assignment. The "value assignment" states it used "replicate analyses" and a "representative sampling of this lot of product." The exact number of replicates or product units sampled is not specified.
Data Provenance: The studies were performed by "the manufacturer and/or independent laboratories." No specific country of origin is mentioned for the data, and it is assumed to be retrospective to the manufacturing process for the specific lot.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. For a quality control material, "ground truth" is established through analytical methods and value assignments, not expert consensus on interpretations like in diagnostic imaging. The values are assigned based on "replicate analyses" using "manufacturer supported reagents."

4. Adjudication method for the test set

Not Applicable. As there are no expert interpretations or subjective assessments involved in the performance evaluation of a quality control material, no adjudication method would be used. Value assignment is typically based on rigorous statistical analysis of quantitative measurements.

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 a diagnostic device that involves human readers or AI assistance.

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

Not Applicable. This is a quality control material. There is no algorithm involved.

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

For quality control materials, the "ground truth" (or accepted reference values) for the analytes within the control is established through analytical testing and quantitative measurement. The document states, "The mean values and the corresponding ±3SD ranges printed in the insert were derived from replicate analyses and are specific for this lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents." This indicates a measurement-based analytical ground truth.

8. The sample size for the training set

Not Applicable. This is a quality control product; there is no machine learning "training set."

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

Not Applicable. As there is no training set.

Summary

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K121794

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Bio-Rad Laboratories Premarket Notification Section 510 (k) Liquichek Urine Chemistry Control

Summary of Safety and Effectiveness Liquichek Urine Chemistry Control

1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, Callfornia 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

June 15th, 2012

2.0 Device Identification

Product Trade Name:	Liquichek Urine Chemistry Control
Common Name:	Multi-Analyte Controls, All Kinds (Assayed)
Classifications:	Class I, reserved
Product Code:	JJY
Regulation Number:	21 CFR 862.1660

Device to Which Substantlal Equivalence is Claimed 3.0

Liquichek Urine Chemistry Control Bio-Rad Laboratories Irvine, California

510 (k) Number: K020817

Description of Device 4.0

Value Assignment 5.0

The mean values and the corresponding ±3SD ranges printed in the insert were derived from replicate analyses and are specific for this lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides. Laboratory established ranges may vary from those listed during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacturer test method modifications.

1 1 2012 JUL

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6.0 Intended Use

Liquichek Urine Chemistry Control is intended for use as an assaved quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

7.0 Comparison of the new device with the Predicate Device

Liquichek Urine Chemistry Control claims substantial equivalence to the Liquichek Urine Chemistry Control currently in commercial distribution (K020817). 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 Chemistry Control( New Device )	Liquichek Urine Chemistry Control( Predicate Device, K020817 )
Similarities
Intended Use	Liquichek Urine Chemistry Control isintended for use as an assayed qualitycontrol urine to monitor the precision oflaboratory testing procedures for theanalytes listed in this package insert.	Liquichek Urine Chemistry Control isintended for use as an assayed qualitycontrol urine to monitor the precision oflaboratory testing procedures for theanalytes listed in this package insert.
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
Storage unopened (Shelf life)	2 to 8°C until expiration date	2 to 8°C until expiration date
Differences
Fill Volume	For Level 1 and 2 - 12 x 2.5 mLFor Bilevel MiniPak - 2 x 2.5 mL	For Level 1 and 2 - 12 x 10 mLFor Bilevel MiniPak - 2 x 10 mL
Analytes	Contains:AmylaseCalciumChlorideCreatinineGlucoseMagnesiumMicoalbumin (Albumin)PhosphorusPotassiumProtein, TotalSodiumUrea Nitrogen (BUN)Uric AcidDoes not containUreaCortisolOsmolalitypHPregnancySpecific Gravity	Contains:AmylaseCalciumChlorideCortisolCreatinineGlucoseMagnesiumMicoalbumin (Albumin)OsmolalityPhosphoruspHPregnancyPotassiumProtein, TotalSpecific GravitySodiumUreaUrea Nitrogen (BUN)Uric Acid

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

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Bio-Rad Laboratories Premarket Notification Section 510 (k) Liquichek Urine Chemistry Control

8.0 Statement of Supporting Data

Stability studies have been performed for Liquichek Urine Chemistry control to determine the open vial and shelf life claims. Product claims are as follows:

Open Vial:

Shelf Life Stability

30 days at 2 to 8°C. 24 Months at 2°C to 8°C

Conclusion 9.0

Liquichek Urine Chemistry control is intended to be used for the same purpose as the predicate device. It has the human urine matrix and performs similarly as the predicate device.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Bio-Rad Laboratories c/o Suzanne Parsons 9500 Jeronimo Road Irvine, CA 92618-2017

Re: K121794 JUL 11 2012

Trade Name: Liquichek Urine Chemistry Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (assayed) Regulatory Class: Class I, reserved Product Codes: JJY Dated: June 18, 2012 Received: June 19, 2012

Dear Suzanne Parsons:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 17 you desire specific ad rive to: Device Evaluation and Safety at (301) 796-5450. Also, commor the regulation entitled, "Misbranding by reference to premarket notification" (21 please note the rogulation regarding postmarket surveillance, please contact CDRB13 Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Office of But romance and garding 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 Tou may 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/ResourcesforYou/Industry/default.htm

Sincerely yours,

signature

Countney 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

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Indications for Use Form

K121794 510(k) Number (if known):

Device Name:

Liquichek Urine Chemistry control

Indications for Use:

Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

The following analytes are listed in the package insert:

Amylase
Calcium
Chloride
Creatinine
Glucose
Magnesium
Microalbumin (Albumin)
Phosphorus
Potassium
Protein, total
Sodium
Urea Nitrogen (BUN)
Uric Acid

× 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)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 14121794 510(K)

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Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.