(24 days)
Intended for the in vitro quantitative determination of total Homocysteine in serum and plasma to assist in the diagnosis and treatment of patients suspected in having homocystinuria and hyperhomocysteinemia.
The Liquid Stable (LS) 2-Part Homocysteine Reagent will consist of two (2) reagents plus calibrators. The first reagent (LS-R1) will include Lactic Acid Dehydrogenase (LDH), Serine, and ß-Nicotinamide Adenine Di-Nucleotide reduced Di-Sodium Salt (NADH) with buffers and stabilizers. The fill volume will be 30 to 50 mL, depending on the kit configuration. The second reagent (LS-R2) will include Cystathionine B-Synthase (CBS) and Cystathionine B-Lyase (CBL) enzymes with buffers and stabilizers. The fill volume will be 7 mL for all kit configurations. The calibrators will include two (2) bottles; Calibrator "A" will be 0 µmoles/L and Calibrator "D" will be 25-30 umoles/L. The fill volume for the calibrators will be 3 mL.
This document is a 510(k) Special Premarket Notification for the Liquid Stable (LS) 2-Part Homocysteine Reagent. It details the device's characteristics and compares it to a legally marketed predicate device to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device, K011689 Homocysteine Enzymic Homocysteine Reagent. The new device is considered to meet acceptance criteria if its performance is "Same" or comparable to the predicate device, especially for the "Correlation coefficient" and "Precision".
| Performance Metric | Acceptance Criteria (Predicate K011689) | Reported Device Performance (Liquid Stable (LS) 2-Part Homocysteine Reagent) |
|---|---|---|
| Correlation coefficient (compared to Abbott FPIA assay for predicate) | >0.95 (0.993) | >0.95 (0.997) (compared to current Homocysteine Enzymic Homocysteine Reagent) |
| Precision (within run) | ||
| Low | CV 3.5% | CV 2.3% |
| Mid | CV 2.5% | CV 1.8% |
| High | CV 2.1% | CV 1.3% |
| Precision (total) | ||
| Low | CV 5.6% | CV 4.3% |
| Mid | CV 4.7% | CV 2.8% |
| High | CV 3.8% | CV 2.4% |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It refers to performance data obtained when compared to other reagents, but the details of the samples used for these comparisons are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study focuses on comparing the new reagent's analytical performance against a predicate device, not on diagnostic interpretations requiring expert ground truth in the typical clinical sense.
4. Adjudication method for the test set
This information is not applicable and therefore not provided, as the study is an analytical performance comparison of a diagnostic reagent, not a clinical study involving human readers or interpretations.
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
An MRMC comparative effectiveness study was not done. This document describes an analytical performance evaluation of an in vitro diagnostic reagent, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to the described device. The device is a chemical reagent, not an algorithm. The "standalone" performance is effectively the reported correlation coefficient and precision data, which are laboratory measurements of the reagent's analytical accuracy and reproducibility.
7. The type of ground truth used
The "ground truth" for this type of analytical validation is implicitly the performance of the established comparison methods:
- The "current Homocysteine Enzymic Homocysteine Reagent" for the correlation study.
- The Abbott FPIA assay (for the predicate device's correlation, which the new device aims to match or exceed).
The measurements obtained from these established methods are considered the reference or "ground truth" against which the new reagent's performance is assessed.
8. The sample size for the training set
This information is not applicable. The device is a chemical reagent, which does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this type of device.
§ 862.1377 Urinary homocystine (nonquantitative) test system.
(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.