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.

AI/ML Overview

The provided text describes a medical device called "Liquichek™ Cardiac Markers Control LT" and its 510(k) submission to the FDA. This document is a premarket notification for a Class I quality control material. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not involve clinical studies with human subjects or AI algorithms. As such, many of the requested categories for acceptance criteria and study details are not applicable.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (quality control material), the "acceptance criteria" relate to its stability and performance as a control. The document focuses on demonstrating that the new device meets these expectations, particularly in comparison to its predicate.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Intended Use	For use as an assayed quality control serum to monitor the precision of laboratory testing procedures	The new device meets this intended use, identical to the predicate device.
Form	Liquid	The new device is in liquid form, identical to the predicate device.
Matrix	Human serum based	The new device is human serum based, identical to the predicate device.
Storage (Unopened)	-20°C or colder; Until expiration date	The new device requires storage at -20°C or colder until its expiration date, identical to the predicate device.
Open Vial Stability	All analytes stable for 10 days, with NT-proBNP stable for 5 days.	"All analytes will be stable for 10 days with the following exceptions: NT-proBNP will be stable for 5 days." This is a specific claim made by the manufacturer based on their stability studies.
Shelf Life	2 years at -20°C or colder	"2 years at -20°C or colder." This is a specific claim made by the manufacturer based on their stability studies, with real-time studies reported as ongoing to support this claim.
Composition (Analytes)	Includes NT-proBNP, CK-MB Isoenzyme, Digitoxin, Homocysteine, Myoglobin, Troponin I, Troponin T	The new device contains these specified analytes. The predicate device did not contain NT-proBNP. The inclusion of NT-proBNP in the new device is a key difference. The device performance here is simply that it contains these analytes and is intended to function as a control for them.
Number of Levels	Levels 1, 2, 3 and Low Level	The new device offers these four levels. The predicate device only offered Levels 1, 2, and 3. The device performance here refers to its composition including these levels.

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

This information is not provided in the document. The document refers to "Stability studies" and "real time studies" but does not detail the sample sizes (e.g., number of lots, vials tested), the specific experimental design, or the provenance of the data beyond being conducted by Bio-Rad Laboratories. Given this is a control material, the "test set" would likely refer to samples of the control material itself used for various stability and performance assessments, rather than patient data.

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 for this type of device. "Ground truth" in the context of diagnostic interpretation by experts is not relevant for a quality control material. The "truth" for a control material is its assayed value and its stability parameters, determined through chemical and analytical testing procedures.

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

This is not applicable. Adjudication methods are typically used in clinical studies where subjective interpretation or discordance among experts requires resolution. For a quality control material, analytical methods are used to determine performance.

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 and was not done. The device is a quality control material, not an AI-powered diagnostic tool or a device that impacts human reader performance.

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

This is not applicable and was not done. This device is not an algorithm.

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

For this device, the "ground truth" would be established through analytical testing and certified reference materials/methods. The stability claims (open vial, shelf life) and the assayed values for the cardiac markers are determined using validated laboratory procedures and instruments, often calibrated against primary and secondary reference materials. This is an objective chemical/analytical "truth" rather than a subjective expert interpretation.

8. The sample size for the training set

This is not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense. The manufacturer would have internal R&D data from various batches and experiments to establish the product's characteristics, but this isn't a "training set."

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

This is not applicable for the same reasons as point 8.

Summary

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

MAR 1 0 2004

Summary of Safety and Effectiveness Liquichek™ Cardiac Markers Control LT

KD40277

1.0 Submitter

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

Contact Person

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

Date of Summary Preparation

February 4, 2004

2.0 Device Identification

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

3.0 Device to Which Substantial Equivalence is Claimed

Bio-Rad Laboratories Irvine, California

Liquichek™ Cardiac Markers Control LT Docket Number: K021498

4.0 Description of Device

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.

5.0 Statement of Intended Use

Liguichek 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.

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.

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

Comparison of the new device with the Predicate Device 7.0

Liquichek Cardiac Markers Control LT claims substantial equivalence to the Liquiche distibution Liquichek Gardiac Markers Control Cardiac Markers Control currently in commercial distribution. Markers Control LT and Elquicher Corticity of Claimston Court (Level 1, 2, 3 and Low The Tew Liquicher Octular Manere Outlier of the effect is a tri-level product and does not contain NT-proBNP.

Characteristics	Bio-RadLiquichek™ Cardiac Markers Control LT(New Device)	Bio-RadLiquichek™ Cardiac Markers Control LT(Predicate Device K021498)
Similarities
Intended Use	Liquichek Cardiac Markers Control LT is intended for use as anassayed quality control serum to monitor the precision of laboratorytesting procedures listed in the package insert.	Liquichek Cardiac Markers Control LT is intendedfor use as an assayed quality control serum tomonitor the precision of laboratory testingprocedures listed in the package insert.
Form	Liquid	Liquid
Matrix	Human serum based	Human serum based
Storage(Unopened)	-20°C or colderUntil expiration date	-20°C or colderUntil expiration date
Differences
Number of Levels	Levels 1, 2, 3 and Low Level	Levels 1, 2 and 3 (does not contain Low Level)
Open Vial ClaimAt 2-8°C	All analytes will be stable for 10 days with the following exceptions:NT-proBNP will be stable for 5 days.	Troponin-I, Troponin T and Homocysteine: 10 days.Myoglobin, CK-MB, and Digitoxin: 20 days
Analytes	Contains:NT-proBNPCK-MB IsoenzymeDigitoxinHomocysteineMyoglobinTroponin ITroponin T	Contains: Troponin-I, Troponin T, Myoglobin,CK-MB, Homocysteine and DigitoxinDoes not contain: NT-pro BNP

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

2.0 STATEMENT OF SUPPORTING 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: All analytes will be stable for 10 days with the following exceptions: NT-proBNP will be 2.1 stable for 5 days. .
2.2 Shelf Life: 2 years at -20°C or colder
2.3 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.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three lines forming its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the circumference of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 0 2004

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

K040277 Re: 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 Product Code: JJY Dated: February 4, 2004 Received: February 5, 2004

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). 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

{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,

Jean M. Cooper MS, D.V.M.
Jean M. Cooper, MS, D.V.M.

Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known):

K040277

Device Name:

Liquichek™ Cardiac Markers Control LT

Indications For Use:

For use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Carl Benson
__
Division Sign-Off

Office of In Vitro Diagnostic on and safety

510(k) K040277

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)

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.