FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This reagent is based on the formulation of Allain et al. and the modification of Roeschlaus with further improvements to render the reagent stable in solution.

Cholesterol esters are enzymatically hydrolyzed by cholesterol esterase (CE) to cholesterol 1. and free fatty acids. Cholesterol Esters CE Cholesterol + Fatty Acids
Free cholesterol, including that originally present, is then oxidized by cholesterol oxidase 2. (CO) to cholest-4-en-3-one and hydrogen peroxide .. Cholesterol + O2 CQCQ Cholest-4-en-3-one + H2O2
1. The hydrogen peroxide combines with hydroxybenzoic acid (HBA) and 4aminoantipyrine (AAP) in the presence of peroxidase (POD) to form a chromophore (quinoneimine dye) which may be quantitated at 500-550 nm. For bichromatic analyzers the blank wavelength should be set to 600 or 650 nm. 2H2O2 + HBA + 4AAP POD> Quinoneimine Dye + 4H2O

AI/ML Overview

This 510(k) notification for the INFINITY™ Cholesterol Reagent (K980667) does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of a typical AI/ML medical device submission.

Instead, this document is a notification for a reagent (an in vitro diagnostic product) and focuses on demonstrating substantial equivalence to a previously cleared device. Therefore, many of the requested categories related to AI/ML device studies (sample sizes, expert ground truth, MRMC studies, standalone performance) are not applicable here.

Here's a breakdown based on the provided text, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain a table of acceptance criteria or a detailed report of device performance in the way an AI/ML device submission would, with metrics like sensitivity, specificity, or AUC.
The primary "performance" stated is that the new reagent is "substantially equivalent to, and is the same product as the TRACE Scientific Cholesterol Reagent Kit cleared by FDA as K962890." This implies that its performance (accuracy, precision, linearity, etc.) is expected to be comparable to the predicate device. However, specific values are not provided in this public summary.

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

Not applicable / Not provided. The document is for a reagent, not an AI/ML device that uses a "test set" of patient data for performance evaluation in the usual sense. Performance testing for reagents would typically involve laboratory validation studies using reference materials, spiked samples, and patient samples, but the details (sample sizes, provenance) are not included in this summary.

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

Not applicable. This concept of "expert ground truth" is relevant for AI/ML devices interpreting images or data where human experts provide labels. For a cholesterol reagent, the "ground truth" would be established by reference methods or certified reference materials in a lab setting.

4. Adjudication method for the test set:

Not applicable. As above, this is for AI/ML device evaluations.

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 explicitly for AI/ML devices where human readers might interact with AI.

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

Not applicable. This is for AI/ML algorithms. The reagent performs a chemical reaction, not an algorithmic interpretation.

7. The type of ground truth used:

For an in vitro diagnostic reagent, the "ground truth" would generally be established by:
- Reference methods: Highly accurate and precise laboratory methods (e.g., isotope dilution mass spectrometry for cholesterol) for comparison.
- Certified Reference Materials (CRMs): Materials with assigned analyte values determined through rigorous testing.
- Method comparison studies: Comparing results from the new reagent with an established, FDA-cleared method (the predicate device in this case).
The specific methods for establishing ground truth for the reagent's performance claims (implied by substantial equivalence) are not detailed in this summary.

8. The sample size for the training set:

Not applicable / Not provided. Reagents generally don't have "training sets" in the AI/ML sense. Development involves formulation, optimization, and stability testing, not retrospective data training.

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

Not applicable.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The core of this 510(k) is the claim of Substantial Equivalence. The "study" indicated here is implicitly a comparison between the INFINITY™ Cholesterol Reagent and its predicate, the TRACE Scientific Cholesterol Reagent Kit (K962890). The acceptance criteria for this type of submission are that the new device (reagent) performs as well as or in a manner comparable to the predicate device for its intended use. This would typically involve:

Analytical Performance Studies: Comparing accuracy, precision, linearity, limit of detection, interference, etc., of the new reagent against the predicate.
Clinical Performance Studies (less common for reagents unless there's a novel claim): Demonstrating the reagent provides clinically relevant results comparable to the predicate.

However, the specific data from these studies, including acceptance criteria and detailed results, are not present in this public 510(k) summary. The summary simply states the conclusion of substantial equivalence.

Summary

Regulation Number and Section

§ 862.1175 Cholesterol (total) test system.

(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.