LogoFDA 510(k) Search
K Number
K992741
Device Name
LYPHOCHEK ANEMIA CONTROL, MODEL 500
Manufacturer
BIO-RAD
Date Cleared
1999-11-09

(85 days)

Product Code
JJY
Regulation Number
862.1660
Type
Traditional
Panel
Immunology
Reference & Predicate Devices
K812635
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Lyphochek Anemia Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the product insert.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) summary for the Bio-Rad Lyphochek Anemia Control, which is a quality control serum. This type of device is classified as a Class I multi-analyte control and is primarily intended to monitor the precision of laboratory testing procedures.

Regulatory submissions for quality control materials, like the Lyphochek Anemia Control, typically do not involve studies with "acceptance criteria" or "proving a device meets criteria" in the same way that a diagnostic device or an AI/ML algorithm would. These products are assessed for their manufacturing quality, stability, and suitability for their intended purpose as assayed controls. The focus is on demonstrating substantial equivalence to an existing legally marketed predicate device, rather than proving a specific performance metric against a clinical ground truth.

Therefore, the requested information elements related to AI algorithm performance, human reader studies, ground truth establishment, and sample sizes for training/test sets are not applicable to this type of device and are not found in the provided 510(k) summary.

The document states that the device is "substantially equivalent" to the predicate device Bio-Rad Lyphochek Anemia Control (K812635), implying that it performs similarly and has the same intended use.

Here's a breakdown of the applicable information:

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

    • Not applicable in the context of an AI/ML algorithm or diagnostic device. For a quality control material, acceptance criteria would typically relate to manufacturing specifications, stability, and analyte values falling within specified ranges. This information is usually found in the product's internal design controls and quality assurance documentation, not typically in the public 510(k) summary, which focuses on substantial equivalence for regulatory clearance. The 510(k) summary provided does not contain specific performance data or acceptance criteria tables as would be expected for a diagnostic or AI device.

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

    • Not applicable. There is no "test set" in the context of an AI/ML algorithm evaluation for this type of quality control product. Substantial equivalence is generally demonstrated through comparison of device characteristics, manufacturing processes, and intended use to a predicate, not through a performance study on a test set of patient data.

  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. No ground truth for a test set is established for a quality control material in this regulatory context.

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

    • Not applicable. No test set or adjudication for ground truth is described.

  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 device is a quality control product, not an AI-assisted diagnostic tool.

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

    • Not applicable. This is not an algorithm-based device.

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

    • Not applicable. For a quality control material, the "ground truth" (or target values) for its analytes are typically assigned through a robust value assignment process by the manufacturer, often using reference methods and/or multiple instruments. This is part of the product's characterization and not a "ground truth" derived from clinical cases for performance evaluation.

  8. The sample size for the training set:

    • Not applicable. This is not an AI/ML device, so there is no training set.

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

    • Not applicable. No training set.

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.