CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E by CLINIQA CORPORATION

CLINIQA Liquid QC™ Bilirubin Controls Levels 1, 2 & 3 are intended for use as an assayed quality control material. Three assayed levels of Total and Direct Bilirubin are provided.
CLINIQA LiniCAL™ Bilirubin 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 Total and Direct Bilirubin at five useful concentrations.

Device Description

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for CLINIQA Liquid QC™ Bilirubin Controls Levels 1, 2 & 3 and CLINIQA LiniCAL™ Bilirubin Calibration Verifiers Levels A-E for Olympus AU Systems™.

This document does not describe a study that proves the device meets acceptance criteria in the way typically expected for an AI/CADe device or a new diagnostic tool with performance metrics like sensitivity, specificity, or AUC. Instead, this is an approval for quality control materials and calibration verifiers.

The approval for these types of devices is based on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than a clinical efficacy study with acceptance criteria and performance metrics against a ground truth in the same manner.

Therefore, many of the requested elements (e.g., sample size for the test set, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable to this specific type of device and approval process.

However, I can extract the "indications for use" which define the intended function of the device.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this approval is for quality control materials and calibration verifiers based on substantial equivalence, there are no specific performance "acceptance criteria" or "reported device performance" in terms of clinical sensitivity/specificity provided in this document. The "performance" in this context is their ability to function as intended: to serve as assayed quality control materials or calibration verifiers.

Acceptance Criteria (Implied by Indications for Use and Substantial Equivalence Determination)	Reported Device Performance (Implied by Substantial Equivalence and Approval)
CLINIQA Liquid QC™ Bilirubin Controls: Intended for use as an assayed quality control material. Three assayed levels of Total and Direct Bilirubin are provided.	The device is deemed substantially equivalent to legally marketed predicate devices for its intended use as assayed quality control material for Total and Direct Bilirubin.
CLINIQA LiniCAL™ Bilirubin Calibration Verifiers: Assayed, liquid, quality control products used to evaluate the performance of the Olympus AU Systems™ for Total and Direct Bilirubin at five useful concentrations.	The device is deemed substantially equivalent to legally marketed predicate devices for its intended use as assayed, liquid, quality control products to evaluate Olympus AU Systems™ performance for Total and Direct Bilirubin at five concentrations.

2. Sample size used for the test set and the data provenance:

Not Applicable. The approval is not based on a clinical test set in the conventional sense for diagnostic performance. Substantial equivalence typically relies on comparing the device's characteristics (e.g., formulation, intended use, manufacturing process) to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. Ground truth in the clinical diagnostic sense is not established for this type of device's approval.

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

Not Applicable. No test set or adjudication method described.

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 not an AI/CADe device, and no MRMC study was conducted or is relevant to this approval.

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

Not Applicable. This is not an algorithm-based device.

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

Not Applicable. For quality control materials, ground truth would refer to the traceable values of the analytes themselves, established through reference methods and certified reference materials, rather than clinical outcomes or expert consensus on patient cases. However, this level of detail regarding the establishment of values for the controls/calibrators is not part of the 510(k) summary provided. The approval is for the product's function as a control/verifier based on substantial equivalence.

8. The sample size for the training set:

Not Applicable. No training set is relevant for this type of device approval.

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

Not Applicable. No training set is relevant for this type of device approval.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is composed of three thick, curved lines that form the shape of the bird's body and wings. The seal is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 8 2005

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

K052679 Re:

Trade/Device Name: CLNIQA Liquid QC™ Bilirubin Controls Levels 1, 2 & 3 CLINIQA LiniCAL™ Bilirubin Calibration Verifiers Levels A-E for Olympus AU Systems™ Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: September 26, 2005 Received: September 28, 2005

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. Ilsting 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 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 (240) 276-0484. Also, please nother the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Art from the Division of Small Manufacturers, International and Consumer Assistance at its tolloffree number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Alberto G.

Alberto Gutierrez, Ph.D. 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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510(k) Number (if known): Ko 52679

Device Name: CLINIQA Liquid QC™ Bilirubin Controls Levels 1, 2 & 3

Indications For Use:

CLINIQA Liquid QC™ Bilirubin Controls Levels 1, 2 & 3 are intended for use as an assayed quality control material. Three assayed levels of Total and Direct Bilirubin are provided.

Device Name: CLINIQA LiniCAL™ Bilirubin Calibration Verifiers Levels A - E for Olympus AU Systems™ .

Indications For Use:

CLINIQA LiniCAL™ Bilirubin 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 Total and Direct Bilirubin at five useful concentrations.

Prescription Use X

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Tracy Phillips
Division Sign-Off

510(k)_K052679

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.