K-ASSAY HAPTOGLOBIN by KAMIYA BIOMEDICAL CO.

The K-ASSAY Haptoglobin Assay is intended to be used for the quantitative determination of Haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in human serum by immunoturbidimetric assay. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) relating to the formation of hemoglobin complexes and certain kidney diseases. FOR IN VITRO DIAGNOSTIC USE.

Device Description

Not Found

AI/ML Overview

Here's an analysis based on the provided FDA 510(k) clearance letter and Indications for Use statement for the K-ASSAY Haptoglobin device.

It's important to note that this document is an FDA clearance letter, which means it confirms substantial equivalence to a predicate device. It typically does not contain the full details of the study that established the device's performance against specific acceptance criteria in the way a clinical trial report or a comprehensive validation study might. Many of the requested details (like sample size, ground truth establishment, expert qualifications, etc., for AI performance) are not applicable or not present here because this is for an In Vitro Diagnostic (IVD) assay, not an AI/ML-based diagnostic device.

However, I will extract what is relevant and indicate where information is not available from the provided text.

Device: K-ASSAY Haptoglobin

Device Type: In Vitro Diagnostic (IVD) assay (immunoturbidimetric assay)

Intended Use: Quantitative determination of Haptoglobin in human serum to aid in the diagnosis of hemolytic diseases and certain kidney diseases.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria or detailed performance metrics from a validation study. For IVD devices like this one, acceptance criteria would typically involve analytical performance characteristics (e.g., precision, accuracy, linearity, reportable range, interference) and potentially clinical performance (e.g., correlation with clinical status or another accepted method).

The FDA's review for a 510(k) involves determining substantial equivalence to a legally marketed predicate device. This implies that the sponsor demonstrated the new device performs "as safely and effectively as" a predicate, but the specific numerical benchmarks of that comparison are not in this letter.

Performance Metric (Hypothetical for IVD)	Acceptance Criteria (Not specified in document)	Reported Device Performance (Not specified in document)
Analytical Performance
Precision (e.g., CV%)	e.g., ≤ X%	Not stated
Accuracy (e.g., % bias)	e.g., within Y% of reference method	Not stated
Linearity Range	e.g., A - B mg/dL	Not stated
Limit of Detection (LoD)	e.g., ≤ C mg/dL	Not stated
Clinical Performance
Correlation with predicate device	e.g., r ≥ 0.95	Implied to be sufficient for substantial equivalence

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

Not explicitly stated in the provided document.
For IVD assays, test sets would include patient samples (serum in this case) covering the expected analytical range and potentially clinical conditions.
Data Provenance: Not specified. Typically, clinical samples might be from various clinical sites.
Retrospective or Prospective: Not specified. Could be either or a combination.

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

Not applicable in the context of this being an IVD assay clearance.
Ground truth for an IVD assay usually refers to the true concentration of the analyte, often established by a gold standard reference method or laboratory. It doesn't typically involve multiple human experts interpreting data for a diagnostic decision.

4. Adjudication method for the test set

Not applicable. As above, this is for an IVD assay, not a device requiring human interpretation adjudication.

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 an IVD assay, not an AI-assisted diagnostic device. Therefore, no human reader improvement with AI assistance would be studied or reported here.

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

Not applicable. This is an IVD assay that quantifies a biomarker. Its "performance" is its analytical accuracy and precision in measuring haptoglobin, not an algorithmic interpretation of an image or other complex data.

7. The type of ground truth used

Implied ground truth: For an IVD assay, the ground truth would be the true concentration of Haptoglobin in a sample. This is typically established by:
- Reference materials/calibrators: Samples with precisely known concentrations.
- Comparison methods: Results from a well-established, often predicate or gold-standard, analytical method.
- Clinical correlation: Demonstrating that the measured Haptoglobin levels correlate with the presence or absence of the intended clinical conditions (hemolytic diseases, kidney diseases).
Not explicitly detailed in the document.

8. The sample size for the training set

Not applicable in the AI/ML sense. For an IVD assay, there isn't a "training set" in the context of machine learning. There would be samples used during assay development and optimization (which might be analogous to "training data" in a very broad sense) and then independent validation samples. The size of these development samples is not specified.

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

Not applicable in the AI/ML sense. As above, the concept of "ground truth for a training set" as it pertains to AI/ML models does not directly apply to the development of this type of immunoturbidimetric IVD assay. The accuracy of the assay is established through analytical validation against known concentrations and comparison with established methods.

Summary

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NOV 2 4 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188

K993480 Re: Trade Name: K-ASSAY Haptoglobin Regulatory Class: II Product Code: DAD Dated: October 11, 1999 Received: October 14, 1999

Dear Mr. Getty:

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 OS 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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):	K993480
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Device Name: K-ASSAY Haptoglobin.

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number	12993488
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Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use

Optional Format 1-2-96)

Regulation Number and Section

§ 866.5460 Haptoglobin immunological test system.

(a)
Identification. A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.(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 § 866.9.