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

Here's a breakdown of the acceptance criteria and study information for the Liquichek™ Cardiac Markers Control LT device, based on the provided text:

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

The provided document describes a quality control material, not a diagnostic device with performance metrics like sensitivity, specificity, or accuracy for diagnosing a condition. Therefore, the "acceptance criteria" are related to the stability and integrity of the control material itself, rather than diagnostic performance.

Acceptance Criterion	Reported Device Performance
Open Vial Stability	Once thawed and opened, all analytes stable for 7 days when tightly capped at 2-8°C. Exceptions: Troponin I and Homocysteine stable for 10 days.
Refreezing	Control material should not be refrozen after thawing.
Shelf Life	Two years when stored at -20°C or colder.

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

The document does not explicitly state the "sample size" in terms of a number of patient samples, as this is a control material. Instead, stability studies were performed. The sample size for these studies is not specified (e.g., how many vials were tested, how many replicates).

Data Provenance: Not specified, but likely Bio-Rad Laboratories' internal testing, which is based in Irvine, California, USA.
Retrospective or Prospective: The stability studies described are prospective in nature ("Real time studies will be ongoing to support the shelf life of this product").

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 is not applicable to a quality control material. The "ground truth" for a control material is its expected concentration values for various analytes, which are established by the manufacturer through rigorous analytical methods using reference materials and internal standards. Experts are not typically involved in establishing the "ground truth" of a control material in the same way they would for a diagnostic test interpreting patient data.

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

Not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations for diagnostic studies. For a quality control material, the performance is measured against established analytical stability criteria.

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-powered diagnostic device, and thus no human reader studies are relevant.

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

Not applicable, as this is not an algorithm or AI device. It's a laboratory reagent.

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

For a quality control material, the "ground truth" for stability studies is based on:

Reference analytical methods: Ensuring the analytes remain within specified concentration ranges over time under various storage conditions.
Manufacturer's specifications: The established target ranges and acceptable variations for each analyte within the control material.
Stability testing protocols: Standardized procedures to assess degradation or changes in analyte concentration.

8. The sample size for the training set

Not applicable, as this is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary

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Summary of Safety and Effectiveness Liquichek™ Cardiac Markers Control LT

012656

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 Regulatory Affairs Specialist Telephone: (949) 598-1367

Date of Summary Preparation

August 7, 2001

2.0 Device Identification

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

CFR 862.1660 Regulation Number:

Device to Which Substantial Equivalence is Claimed 3.0

Liquichek™ Cardiac Markers Control LT Bio-Rad Laboratories Irvine, California

Docket Number: K980556

Description of Device 4.0

5.0 Statement of Intended Use

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.

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Comparison of the new device with the Predicate Device 6.0

The new Liquichek™ Cardiac Markers Control LT claims substantial equivalerce to the The Trew Equichers Control LT currently in commercial distribution (K980556). Elquichek™ Cardiac Markers Control LT contains Homocysteine and Digitoxin
The new Liquichek™ Cardiac Markers Control LT contains Homocysteine and Digitoxin The new Liquicher - Ourdiae Markers Control Liquichek™ Cardiac Markers Control LT does not contain CK Total, LD-1 Isoenzyme and the current product does.

	Bio Rad	Bio Rad
Characteristics	Liquichek™ Cardiac Markers Control LT(New Device)	Liquichek™ Cardiac Markers Control LT(Predicate Device)
Similarities
IntendedUse	Liquichek™ Cardiac Markers Control LT isintended for use as an assayed qualitycontrol serum to monitor the precision oflaboratory testing procedures for analyteslisted in the package insert.	Liquichek™ Cardiac Markers Control LT isintended for use as an assayed quality controlserum to monitor the precision of an individuallaboratory's specific cardiac markerprocedures.
Form	Liquid	Liquid
Matrix	Human serum based	Human serum based
Differences
Storage(Unopened)	-20°C or colderuntil expiration date	-10 °C to -20°Cuntil expiration date
Open VialClaimAt 2-8°C	Troponin-I and Homocysteine 10 daysMyoglobin, CK-MB, and Digitoxin 20 days	CK, Total, CK-MB, LD-1 Isoenzyme 20 daysMyoglobin, Troponin I, Troponin T 10 days
Analytes	Contains: Troponin-I, Troponin T,Myoglobin, CK-MB, Homocysteine andDigitoxinDoes not Contain: CK Total, LD-1	Contains CK, Total, CK-MB, LD-1 Isoenzyme,Myoglobin, Troponin I, Troponin TDoes not contain: Homocysteine and Digitoxin

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

Summary of Performance Data 7.0

Stability studies have been performed to determine the open vial stability and shelf life or 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 7.1 Open var. Onlo the sentle tightly capped at 2-8℃, with the following exceptions: Troponin I and Homocysteine will be stable for 10 days.
Do not refreeze the control once it has been thawed. 7.2
Shelf Life: Two years when stored at -20 °C or colder 7.3

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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP = 6 2001

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

K012656 Re:

Trade/Device Name: Liquichek Cardiac Markers Control LT Regulation Number: 21 CFR 862.1660 Regulatory Class: I, reserved Product Code: JJT, JJY Dated: August 7, 2001 Received: August 13, 2001

Dear Ms. Platt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to I cachi 1 ood, Drag, and sions of the Act. The general controls provisions of the Act include the goneral controls pro 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarket ripproval), it the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such periodio Crip millions of comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, I DIA may pushine to your premarket notification submission does not affect - 22 cer. I reason wight have under sections 531 through 542 of the Act for devices under the any obligation you mightion Control provisions, or other Federal laws or regulations.

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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 predication. THE I Dr 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 rr you desire specific and vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 101 101 - 10 questions on the promotion and advertising of your device, (201) 597-1500. Traditions 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 mionitation on your roped 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):_K0126562626262

Liquichek™ Cardiac Markers Control LT Device Name:

Indications for Use:

An assayed quality control serum to monitor the precision of laboratory teating procedures for analytes listed in the package insert.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use_

Over-the Counter use_

Kesia Alexander f/k/a Joan Coper
(Division Sign Off)

(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number K012656

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.