The DCL Microalbumin Multi-Calibrator Set, Cat. No. SE-252 is a device intended for medical purposes for use in an albumin test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for the Microalbumin Multi-Calibrator Set, Cat. No. SE-252. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance as one would typically find for a diagnostic test or an AI/ML powered device.

Instead, this document is a regulatory approval for a calibrator set, which is a reference material used to establish points of reference in an albumin test system. The FDA's review here focuses on whether the device is substantially equivalent to legally marketed predicate devices, not on the performance of the device in a clinical study against specific acceptance criteria like accuracy, sensitivity, or specificity.

Therefore, most of the requested information (points 1-9) about acceptance criteria, study design, sample sizes, ground truth, experts, and MRMC studies are not applicable or available in this document.

However, I can extract the following relevant information:

Device Name: Microalbumin Multi-Calibrator Set, Cat. No. SE-252
Intended Use: For IN VITRO diagnostic use as a calibrator for the DCL Microalbumin Assay for quantitation of albumin in human urine.
Regulatory Classification: Class II
Product Code: JIX
Regulation Number: 21 CFR 862.1150 (Calibrator)

To provide an answer to your specific questions, based on the provided text:

A table of acceptance criteria and the reported device performance: This document does not contain a table of acceptance criteria or reported device performance in terms of clinical accuracy or similar metrics. The FDA's decision is based on substantial equivalence to a predicate calibrator, implying that the calibrator performs as expected for its intended use rather than measuring its performance against a specific disease outcome.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable or available in this document. Substantial equivalence for a calibrator typically involves demonstrating the calibrator's values and stability, not performance on a clinical test set.
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): Not applicable or available in this document. Ground truth as typically defined for diagnostic device performance studies is not relevant for a calibrator set's 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or available in this document.
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 device is a calibrator, not an AI-powered diagnostic system or a device that impacts human reader performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a calibrator.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a calibrator, the "ground truth" would relate to the assigned values of the calibrator materials themselves, established through precise analytical methods, rather than clinical outcome or expert consensus. The document does not specify how these values were established, only that it's a calibrator for an in vitro diagnostic test.
The sample size for the training set: Not applicable. Calibrators do not typically have "training sets" in the context of machine learning or complex diagnostic algorithms.
How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory approval for a calibrator, not a performance study for a diagnostic device. The FDA's determination is based on the device being substantially equivalent to existing predicate calibrators, meaning it provides similar performance characteristics for its intended purpose within a larger diagnostic system.

Summary

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Public Health Service

OCT 4 - 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nancy Olscamp Regulatory Affairs Coordinator, External, Diagnostic Division Diagnostic Chemicals Limited 16 McCarville Street Charlottetown, PE Canada CIE 2A6

Re: K042243 Trade/Device Name: Microalbumin Multi-Calibrator Set, Cat. No. SE-252 Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: August 16, 2004 Received: August 19, 2004

Dear Ms. Olscamp:

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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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, M.S., DVM.

Tean 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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Diagnostic Chemicals Limi

510(K) Notification

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Microalbumin Multi-Calibrator Set

Product Cat. No. SE-2

INDICATIONS FOR USE

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510(k) Number:

Device Name:

Microalbumin Multi-Calibrator Set, Cat. No. SE-252

For IN VITRO diagnostic use as a calibrator for the DCL Microalbumin Assay for quantitation of albumin in human urine,

Indications for Use:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

Subpart B -- Clinical Chemistry Test Systems

Sec. 862.1150 Calibrator

The DCL Microalbumin Multi-Calibrator Set, Cat. No. SE-252 is a device intended for medic: ldentification. (a) purposes for use in an albumin test system to establish points of reference that are used in th determination of values in the measurement of substances in human specimens.
Classification. Class II. (b)

Prescription Use: (Part 21 CFR 801 Subpart D)

And/or

Over-the-Counter Use (OTC): (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)

Alfred S. A'
Division Sign-Off

Office of In Vitro Dia Device Evaluation and Safety

510(k) K04/2243

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.