Liquichek™ Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.

Device Description

Liquichek™ Cardiac Markers Control LT is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is provided in liquid form for convenience.

AI/ML Overview

The document describes the device, Liquichek™ Cardiac Markers Control LT, as an assayed quality control serum. The "acceptance criteria" in this context refers to the stability of the analytes within the control serum under specified storage conditions, which determines its shelf life and open-vial stability. The study conducted to "prove the device meets the acceptance criteria" is a series of stability studies.

Here's a breakdown of the requested information based on the provided text:

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

Acceptance Criteria (Measured Performance)	Reported Device Performance
Open Vial Stability (2-8°C, tightly capped)
- Troponin-I, Troponin T, and Homocysteine stability	10 days
- Myoglobin, CK-MB, and Digitoxin stability	20 days
Shelf Life (Unopened, -20°C or colder)	2 years
Preservatives	Contains a broad-spectrum anti-microbial cocktail (<0.1% concentration)
Form	Liquid
Matrix	Human serum based

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

Sample Size: Not explicitly stated. The document mentions "All supporting data is retained on file at Bio-Rad Laboratories," but does not provide details on the number of samples or batches tested for the stability studies.
Data Provenance: The studies were conducted by Bio-Rad Laboratories (Irvine, California, USA). They are described as "stability studies" and "real time studies," suggesting a prospective nature for the shelf-life evaluation.

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)

This type of information is not applicable to this device and study. The device is a quality control material intended to monitor the precision of laboratory procedures. The "ground truth" for its performance is determined by established analytical methods for measuring the stability of the cardiac markers within the control, not by expert interpretation.

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

This is not applicable to this type of device and study. Adjudication methods typically apply to studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For a quality control material, performance is measured against pre-defined analytical specifications.

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 is not applicable to this device. An MRMC study is relevant for diagnostic devices that involve human interpretation and potentially AI assistance. The Liquichek™ Cardiac Markers Control LT is a quality control material, not a diagnostic or AI-assisted diagnostic device.

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

This is not applicable to this device. This concept relates to the performance of an AI algorithm without human intervention, which is not relevant for a quality control material.

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

The "ground truth" for this device's performance is based on the analytical stability of the cardiac markers and other constituents within the control material over time, under specified storage conditions. This is determined through quantitative chemical and biochemical assays, rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable to this device. The Liquichek™ Cardiac Markers Control LT is a chemical control product, not an AI or machine learning algorithm that requires a training set.

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

This is not applicable to this device for the reasons stated in point 8.

Summary

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MAY 24 2002

K021498

Page 1 of 3

Bio-Rad Laboratories Premarket Notification Section 510(k) for Liquichek™ Cardiac Markers Control LT Summary of Safety and Effectiveness

Summary of Safety and Effectiveness Liquichek™ Cardiac Markers Control LT

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

May 8, 2002

2.0 Device Identification

Liquichek™ Cardiac Markers Control LT Product Trade Name: Enzyme Controls, (Assayed and unassayed) Common Name: Class I Classifications: 75JJT Product Code: CFR 862.1660 Regulation Number:

Device to Which Substantial Equivalence is Claimed 3.0

Bio-Rad Laboratories Irvine, California

Liquichek™ Cardiac Markers Control LT Docket Number: K012656

Liquichek™ Cardiac Markers Docket Number: K961828

Description of Device 4.0

Statement of Intended Use 5.0

Liquichek™ Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of laboratory procedures listed in the package insert.

08_SSE_645_cardiac 5/02

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6.0 Preservatives:

The Liquichek™ Cardiac Markers Control LT does not contain sodium azide as a preservative. It contains a broad-spectrum anti-microbial cocktail as a preservative where the concentration of any one ingredient is less than 0.1%. At this low level, these ingredients are not expected to cause a health hazard to the user. And thus, domestic and international regulations do not require this type of information on the vial or box label.

7.0 Comparison of the new device with the Predicate Device

Cardiac Markers Control LT claims substantial equivalence to the Liquichek™ Liquichek™ Cardiac Markers Control LT and Liquichek™ Cardiac Markers Control currently in commercial distribution.

	Bio Rad	Bio Rad	Bio Rad
Characteristics	Liquichek™ Cardiac MarkersControl LT(New Device)	Liquichek™ Cardiac MarkersControl LT(Predicate Device K012656)	Liquichek™ Cardiac MarkersControl(Predicate Device K961828)
Similarities
Intended Use	Liquichek™ Cardiac MarkersControl LT is intended for use as anassayed quality control serum tomonitor the precision of laboratorytesting procedures for analyteslisted in the package insert.	Liquichek™ Cardiac MarkersControl LT is intended for use as anassayed quality control serum tomonitor the precision of anindividual laboratory's specificcardiac marker procedures.	Liquichek Cardiac Markers Controlis intended for use as an assayedquality control serum to monitor theprecision of laboratory testingprocedures listed in the packageinsert.
Form	Liquid	Liquid	Liquid
Matrix	Human serum based	Human serum based	Human serum based
Differences
Storage(Unopened)	-20°C or colderUntil expiration date	-20°C or colderUntil expiration date	-10 °C to -20°CUntil expiration date
Open Vial ClaimAt 2-8°C	Troponin-I, Troponin T andHomocysteine: 10 daysMyoglobin, CK-MB, and Digitoxin:20 days	Troponin-I and Homocysteine10 daysMyoglobin, CK-MB, and Digitoxin20 days	Myoglobin, Troponin I, Troponin T10 daysCK, Total, CK-MB, LD-1 Isoenzyme20 days
Analytes	Contains: Troponin-I, Troponin T,Myoglobin, CK-MB, Homocysteineand Digitoxin	Contains: Troponin-I, Myoglobin,CK-MB, Homocysteine andDigitoxinNo claim is made for expectedvalues or stability of Troponin T.	Contains CK, Total, CK-MB, LD-1Isoenzyme, Myoglobin, Troponin Iand Troponin T.

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

8.0 Summary of Performance Data

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

Open vial: Once the control material is thawed and opened, all analytes will be 8.1 stable for 20 days when stored tightly capped at 2-8°C, with the following exceptions: Troponin I. Troponin T and Homocysteine will be stable for 10 days.
Do not refreeze the control once it has been thawed. 8.2

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Shelf Life: Two years when stored at -- 20 °C or colder 8.3

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are depicted in a simple, abstract manner.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 4 2002

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

Re: K021498

Trade/Device Name: Liquichek™ Cardiac Markers Control LT Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJT Dated: May 8, 2002 Received: May 9, 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, 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 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 or any I vith 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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Page 2 -

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 1 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/cdrb/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): K021498

Device Name: Liquichek™ Cardiac Markers Control LT

Indications for Use:

Liquichek Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use		or	Over-the Counter use
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	Juan Cooper
	(Division Sign-Off)
	Division of Clinical Laboratory Devices
510(k) Number	K021498

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.