GAMMA-B 25-HYDROXY VITAMIN D RIA by IMMUNODIAGNOSTIC SYSTEMS LTD.

The IDS Gamma-B 25-Hydroxy Vitamin D kit is a liquid phase radioimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. For In Vitro Diagnostic Use Only.

Device Description

liquid phase radioimmunoassay

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a diagnostic device. It outlines the regulatory approval for the Gamma-B 25-Hydroxy Vitamin D RIA Kit and states its intended use. However, it does not contain the details of a study that proves the device meets specific acceptance criteria in the way a modern clinical trial or performance study report would.

The letter confirms the device is substantially equivalent to legally marketed predicate devices, which is a regulatory standard for market entry in the US for certain medical devices. This substantial equivalence is typically based on comparing the new device's technological characteristics and performance data to that of a predicate device.

Therefore, the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document, as it focuses on regulatory approval rather than a detailed scientific study report.

Here's a breakdown of what can be inferred or what is missing:

1. A table of acceptance criteria and the reported device performance

Missing from document: This document does not present a table of acceptance criteria or detailed performance data. The FDA's 510(k) clearance process would have reviewed such data, but it's not included in this letter. Performance claims like accuracy, precision, linearity, etc., would typically be in the 510(k) submission itself, not the clearance letter.

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

Missing from document: The document does not specify the sample size used for any test set or the provenance of the data (e.g., country of origin, retrospective/prospective). Such information would be part of the performance study submitted to the FDA.

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

Missing from document: Not applicable for an in vitro diagnostic device like this RIA kit, which measures quantitative levels of a biomarker. "Ground truth" for such devices typically comes from reference methods or established analytical techniques, not expert consensus on images or clinical assessments.

4. Adjudication method for the test set

Missing from document: Not applicable for an in vitro diagnostic device. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving physician interpretation, for example, in imaging diagnostics.

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

Missing from document: Not applicable. This device is a radioimmunoassay kit, not an AI-powered diagnostic tool requiring human interpretation improvement studies.

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

Missing from document: Not applicable. This is not an algorithm, but a laboratory test kit. Its performance is evaluated biochemically.

7. The type of ground truth used

Inferred: For an in vitro diagnostic assay like this, the "ground truth" for evaluating performance would likely involve established reference methods for 25-hydroxy vitamin D quantification (e.g., LC-MS/MS or other validated assays) or certified reference materials, rather than expert consensus, pathology, or outcomes data. This document doesn't explicitly state the ground truth method.

8. The sample size for the training set

Missing from document: Not applicable typically for this type of RIA kit. While there's method development and optimization (which might involve a "training" phase in a general sense), there isn't a "training set" in the machine learning context for which a specific sample size would be reported in the performance evaluation.

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

Missing from document: See point 8. This concept doesn't directly apply here.

Summary

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SEP 1 7 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Paul Puntin Head of Ouality & Regulatory Affairs Immunodiagnostic Systems Ltd. 10 Didcot Way Boldon Business Park Boldon, Tyne & Wear, United Kingdom

Re: K991998

Trade Name: Gamma-B 25-Hydroxy Vitamin D RIA Kit Regulatory Class: II Product Code: MRG Dated: August 5, 1999 Received: August 9, 1999

Dear Mr. Puntin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K K991998

Device Name:

Gamma-B 25-Hydroxy Vitamin D

Indications For Use:

For In Vitro Diagnostic Use Only.

Stern Cooper

(Division Sign-Off)

(Division Sign-Off) Division of Clinical Laboratory Devices K 991999 510(k) Number _

(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

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1825 Vitamin D test system.

(a)
Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.(b)
Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and
(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.