LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS by CLINIQA CORPORATION

CLINIQA LiniCAL™ Chemistry Calibration Verifiers Levels A - E for Olympus AU Systems™ are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems™ for Albumin, Blood Urea Nitrogen, Calcium, Creatinine, Magnesium, Phosphorus, Total Protein, Triglycerides, Glucose, Iron, Sodium, Chloride, and Potassium at five useful concentrations.

Device Description

assayed, liquid, quality control products

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device named "LiniCAL™ Chemistry Calibration Verifiers Levels A- E for Olympus AU Systems™". This letter is for a quality control material and not for a diagnostic device that processes patient data or uses AI. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and AI performance metrics is not applicable to this type of device.

Specifically:

Acceptance Criteria and Reported Device Performance: The document does not describe specific numerical acceptance criteria or performance metrics for this quality control material. The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the primary criterion for 510(k) clearance for this type of device.
Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance: These concepts are relevant to studies evaluating the diagnostic accuracy of a medical device (e.g., an imaging AI product). A calibration verifier is used to check the performance of an analytical instrument (like the Olympus AU Systems™), not to diagnose patients. As such, these types of studies and associated metrics are not performed for this product.
Training Set Information: Training sets, ground truth establishment for training, etc., are terms associated with machine learning or AI model development. This device is a chemical reagent, not an AI product.

Summary based on the document:

Since the device is a quality control material, the typical "acceptance criteria" and "study" as one might expect for a diagnostic or AI-powered device are not present in this regulatory filing. The FDA's acceptance is based on the determination that the device is "substantially equivalent" to legally marketed predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Type	Reported Device Performance	Comments
Substantial Equivalence to Predicate Device	Determined to be substantially equivalent to legally marketed predicate devices.	This is the primary regulatory acceptance criterion for 510(k) clearance for this type of device. Specific performance characteristics are typically detailed in the 510(k) submission itself, but not summarized in the clearance letter as "acceptance criteria."

Information Not Applicable or Not Found in the Provided Text:

Sample size used for the test set and the data provenance: Not applicable for a quality control material.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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 (not an AI device).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (not an AI device).
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable (not an AI device).
How the ground truth for the training set was established: Not applicable (not an AI device).

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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20
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Ruggiero Director of Regulatory Affairs CLINIQA Corporation 1432-B South Mission Road Fallbrook, CA 92028

Re: K033162

Trade/Device Name: LiniCAL™ Chemistry Calibration Verifiers Levels A- E for Olympus AU Systems "M Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: September 26, 2003 Received: September 30, 2003

OCT 1 0 2003

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. Iisting 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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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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: LiniCAL™ Chemistry Calibration Verifiers Levels A – E for Olympus AU Systems ™

Indications For Use:

Allato Sely
Division Sign-Off

Division Sign-Off for Lean Expedite

S.Cr. Life Diagnostic Device

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033162

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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.