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

CLINIQA LiniCAL™ Esoterics 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 Ammonia, Ethanol, Microalbumin, Salicylate, and Urinary/CSF Protein at five useful concentrations.

Device Description

assayed, liquid, quality control products

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a Class I medical device, LiniCAL™ Esoterics Calibration Verifiers. This type of device is a quality control material used to evaluate the performance of diagnostic systems (in this case, Olympus AU Systems™ for specific analytes).

For Class I devices like this, the regulatory burden is significantly lower than for Class II or Class III devices, particularly those involving AI or complex diagnostic algorithms. The clearance is based on "substantial equivalence" to a legally marketed predicate device, not on extensive clinical studies proving device efficacy or meeting detailed performance criteria like those found for AI/ML-driven diagnostics.

Therefore, the information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is generally not applicable or not provided in this type of FDA clearance document for a Class I quality control material.

Here's why and what can be inferred:

Acceptance Criteria and Reported Device Performance:
- Not Applicable in this context. For a quality control material, "performance" would typically refer to its stability, accuracy of its assigned values, and its ability to challenge the assay system across a range of concentrations. The FDA clearance letter itself does not detail specific acceptance criteria for these aspects or present performance data from a pivotal study. Such information would be contained in the 510(k) submission itself, but it's not publicly available in this letter.
- The "performance" implied here is that the device "may be used to evaluate the performance of the Olympus AU Systems™ for Ammonia, Ethanol, Microalbumin, Salicylate, and Urinary/CSF Protein at five useful concentrations." This statement describes its intended function, not quantitative performance metrics.
Sample Size used for the test set and the data provenance:
- Not provided in this document. For a quality control material, testing would involve manufacturing batches, stability studies, and verification of assigned values using reference methods or predicate devices. This is not a "test set" in the sense of patient data for an AI algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a quality control material is established through rigorous analytical chemistry techniques, using reference methods, and often by comparing with established calibrators/controls, not by expert consensus on patient data.
Adjudication method for the test set:
- Not applicable. Adjudication is relevant for subjective interpretation tasks, particularly in image analysis or pathology. This is an objective chemical control.
If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, not done. MRMC studies are specific to diagnostic devices (often imaging) where human readers interpret cases. This is a quality control material for an analytical instrument.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a reagent used by an analytical instrument. It is not an algorithm, nor does it operate "standalone" in the way an AI diagnostic would.
The type of ground truth used:
- Inferred: For a quality control material, the "ground truth" for its assigned values would be established through certified reference materials, traceable analytical methods, and comparisons to established, analytically validated predicate controls/calibrators. It is not pathology, expert consensus, or outcomes data in the usual sense.
The sample size for the training set:
- Not applicable. There is no "training set" for a quality control material in the same way there is for an AI/ML algorithm.
How the ground truth for the training set was established:
- Not applicable. As above, no training set.

In summary: The provided document is an FDA 510(k) clearance for a Class I "Quality Control Material (Assayed and Unassayed)." This type of device does not involve artificial intelligence, machine learning, or complex diagnostic interpretations by human readers, and therefore, the structured questions about acceptance criteria, study methodologies, ground truth establishment, and expert involvement are not pertinent to this device or documented in this type of regulatory letter. The clearance is based on showing substantial equivalence to a predicate device, implying its analytical performance is comparable and safe for its intended use.

Summary

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

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a person embracing or supporting another figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 3 2004

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

K040091 Re: K040071
Trade/Device Name: LiniCALTM Esoterics 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: JJY Dated: January 13, 2004 Received: January 16, 2004

Dear Ms. Ruggiero:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases 976, the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, and excordance with the provisions of the Federal Food, Drug, devices that have been reciasined require approval of a premarket approval application (PMA). and Costicule Act (110.) that to nevies, subject to the general controls provisions of the Act. The r our may, diererere, mains of the Act include requirements for annual registration, listing of general controls proving 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 If your device is olusified (600 acc roy ols. Existing major regulations affecting your device can may oe subject to suel adentifical 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 r lease oc advised that 1 Dr. 5 issuanted evour device complies with other requirements of the Act that I Dri has made a avoid regulations administered by other Federal agencies. You must of any I cut all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Tec of CFR Parts 801 and 809); and good manufacturing practice CFR Part 807), iaooning (21 the quality systems (QS) regulation (21 CFR Part 820).

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

Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I has letter with and in yourse FDA finding of substantial equivalence of your device to a legally prematicated 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, If You desire spoonie navertising 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 Tou may 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, US, 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

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

510(k) Number (if known):

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

Indications For Use:

Alberto Lutz
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040091

(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.