HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER by THE BINDING SITE, LTD.

This kit is intended for the quantification of IgG subclasses in serum on the Hitachi 911 (7070). Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Device Description

Human IgG Subclass Liguid Reagent Kit for use on the Hitachi 911/7070 Turbidimetric Analyzer

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Human IgG Subclass Liquid Reagent Kit":

Based on the provided document, which is an FDA 510(k) clearance letter, it's important to understand that this letter grants clearance based on a demonstration of substantial equivalence to a predicate device. It does not present the detailed study findings or acceptance criteria directly within the letter itself.

The letter refers to the "510(k) premarket notification" as the document that contains the actual study details and data. To answer your questions fully, one would typically need access to the full 510(k) submission, which is not provided here.

However, I can extract what is implied and what is explicitly not present in this particular document:

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

Acceptance Criteria: Not explicitly stated in this document. For an in vitro diagnostic device like this, acceptance criteria would typically involve analytical performance characteristics such as:
- Accuracy/Correlation: Comparison with a reference method or predicate device, often assessed by linear regression (slope, intercept, r-value) and/or bias plots (e.g., Bland-Altman).
- Precision/Reproducibility: Within-run, between-run, and total precision studies (CV%).
- Analytical Measurement Range (AMR): The range over which the device can accurately quantify the analyte.
- Limit of Detection (LoD) / Limit of Quantitation (LoQ): The lowest concentration that can be reliably detected/quantified.
- Interference: Studies demonstrating lack of significant interference from common endogenous and exogenous substances.
- Specificity: Absence of cross-reactivity with related substances.
- Method Comparison: Direct comparison with the predicate device or a gold standard method using clinical samples.
- Clinical Performance: (Less common for new 510(k) analytes with well-established uses, but could involve comparing results with clinical diagnosis or outcomes).
Reported Device Performance: Not explicitly stated in this document. The letter only confirms that the FDA reviewed the submission and found the device substantially equivalent. The actual performance data would be in the 510(k) submission itself.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not specified in this document.
Data Provenance: Not specified in this document.

3. 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/not specified. For an in vitro diagnostic device that quantifies an analyte (IgG subclasses), the "ground truth" is typically established by:
- Quantitative results from a well-characterized reference method or a legally marketed predicate device.
- Certified reference materials or commutable reference materials.
- Pathology (e.g., for calibrator assignment if a new analyte).
Expert consensus is not typically involved in establishing ground truth for quantitative laboratory tests in the same way it is for image interpretation or diagnosis.

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

Not applicable/not specified. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in scenarios involving human interpretation (e.g., image reading, clinical diagnosis), not for quantitative laboratory test results.

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

No, an MRMC comparative effectiveness study was not done. This type of study applies to devices (often AI-based) that assist human readers (e.g., radiologists, pathologists) in interpreting complex data, especially images. This device is an in vitro diagnostic reagent kit for automated turbidimetric analysis, which does not involve human interpretation in the same way.

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

Yes, in essence, this device represents a "standalone" performance. The "algorithm" here is the chemical reaction and optical measurement performed by the Hitachi 911/7070 Turbidimetric Analyzer using the provided reagents. The performance claimed for this device (quantification of IgG subclasses) is its direct analytical output, without requiring human interpretation or assistance for the measurement itself. The results are then used by clinicians for diagnosis.

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

For an in vitro diagnostic device like this, the ground truth for performance studies (e.g., accuracy, method comparison) would typically be:
- Reference method results: Results obtained from a well-established, validated, and often more laborious or expensive laboratory method.
- Predicate device results: Comparison to the quantitative results generated by the legally marketed predicate device.
- Certified Reference Materials (CRMs) / Reference Materials (RMs): Samples with accurately assigned values.

8. The sample size for the training set

Not applicable/not specified. This is a reagent kit for a turbidimetric analyzer. It is not an AI/machine learning device that requires a "training set" in the computational sense. The "training" of such a system involves calibrating the instrument with known standards and ensuring the reagents perform correctly; this is part of standard laboratory practice and manufacturing quality control, not a separate "training set" study for regulatory clearance in the AI context.

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

Not applicable/not specified. As explained above, the concept of a "training set" with established ground truth, as used in AI/ML, does not apply to this type of device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head turned to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 7 2002

The Binding Site, Limited c/o Jay H. Geller West Tower, Suite 4000 2425 West Olympic Boulevard Santa Monica, CA 90404

Re: K021081

Device Name: Human IgG Subclass Liguid Reagent Kit for use on the Hitachi 911/7070 Turbidimetric Analyzer Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A. G. M. D. and E Immunological Test System Regulatory Class: II Product Code: DEZ Dated: May 28, 2002 Received: June 4, 2002

Dear Mr. Geller:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Butman

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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K021081 INDICATIONS FOR USE STATEMENT

Device Name: Human IgG Subclass Liquid Reagent Kit for use on the Hitachi 911/7070 Turbidimetric Analyser

Indications for Use: This kit is intended for the quantification of IgG subclasses in serum on the Hitachi 911 (7070). Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Sousan S. Altaie

(Division Sign-Off) Division of Clinical Labo 510(k) Number .

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

Concurrence of CDHR, office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use_

Regulation Number and Section

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).