LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS by CLINIQA CORPORATION

CLINIQA LiniCAL™ Enzyme Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Beckman Coulter Synchron® System for Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase, Cholinesterase, Creatine Kinase, Creatine Kinase MB, Lactate Dehydrogenase, Lipase, Gamma Glutamyl Tranferase, and Pancreatic Amylase at five useful concentrations.

Device Description

assayed, liquid, quality control products

AI/ML Overview

This is a 510(k) premarket notification for a medical device called "LiniCAL™ Enzyme Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems". This document is a clearance letter from the FDA, not a study report or a detailed technical submission. Therefore, it does not contain the specific details required to fully answer your request regarding acceptance criteria and a study proving device performance.

However, based on the information provided, I can infer some aspects and highlight what is missing:

Missing Information: The provided document is an FDA clearance letter for a Class I device (Quality control material). Such letters generally confirm substantial equivalence to a predicate device and do not typically include detailed study designs, acceptance criteria, or performance data in the same way a premarket approval (PMA) application or a more complex 510(k) for a novel device might.

Regarding the device's performance and acceptance criteria:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in this document. For a quality control material like this, acceptance criteria would typically involve demonstrating that the calibrator material produces expected, consistent, and accurate results when run on the specified Beckman Coulter Synchron® Systems for the listed enzymes, within defined statistical limits (e.g., specific bias, precision, linearity, or recovery ranges). These criteria would have been established internally by CLINIQA.
- Reported Device Performance: Not explicitly reported in this document. The FDA letter confirms the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is comparable and acceptable for its intended use. Performance data would have been submitted in the original 510(k) application, but it is not detailed here.
Hypothetical Example (what would be expected in a detailed submission):

Enzyme	Acceptance Criteria (e.g., % Recovery vs. Reference)	Reported Device Performance (Mean % Recovery)
Alkaline Phosphatase	95-105%	99.8%
Alanine Aminotransferase	98-102%	100.1%
Amylase	95-105%	98.5%
...	...	...

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document. As a quality control material for in vitro diagnostics, the testing would likely be performed in a laboratory setting, typically with controlled samples, rather than patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. For a calibration verifier, "ground truth" would generally be established by highly accurate reference methods or certified reference materials, not typically by expert consensus in the diagnostic sense. The "ground truth" would be the assigned value of the calibrators, likely determined through rigorous analytical testing by CLINIQA and possibly external certified labs, rather than expert judgment on individual cases.
Adjudication method for the test set:
- Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers interpret images or clinical cases and their interpretations need to be reconciled. This is not relevant for a quality control material where performance is assessed through quantitative analytical measurements.
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. This is a calibration verifier, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical quality control material, not a software algorithm. Its performance is evaluated intrinsically on an analyzer, not as a standalone algorithm.
The type of ground truth used:
- Reference Methods/Certified Reference Materials/Assigned Values: For calibration verifiers, the ground truth is the "assigned value" of each level (A-E) for each enzyme. This value would be determined using highly accurate, traceable reference methods or against certified reference materials, ensuring the calibrators' accuracy.
The sample size for the training set:
- Not applicable / Not specified. "Training set" is a concept primarily used in machine learning and AI. For a physical quality control material, there isn't a "training set" in this sense. The manufacturing process is controlled and verified, and the product is characterized, but it's not "trained."
How the ground truth for the training set was established:
- Not applicable. As explained above, the concept of a "training set" and its "ground truth" does not apply to this type of device. The accuracy of the product itself (the calibrators) is established through analytical characterization against reference materials.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing shapes.

Public Health Service

MAR 2 9 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Ruggiero Director of Regulatory Affairs CLINIOA Corporation 1432 South Mission Rd. Fallbrook, CA 92028

Re: K040535

Trade/Device Name: LiniCAL™ Enzyme Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I Product Code: JJY Dated: March 1, 2004 Received: March 2, 2004

Dear Ms. Ruggiero:

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).

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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, DVM.

Yean 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

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K040535 510(k) Number (if known):

Device Name: LiniCAL™ Enzyme Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qeet. D. Heen and for Heen Cooper
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040535

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use

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.