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K Number
K982637
Device Name
IMMULITE PSA CONTROL MODULE, MODEL LPSCM
Manufacturer
DIAGNOSTIC PRODUCTS CORP.
Date Cleared
1998-08-12

(14 days)

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

IMMULITE® PSA Control Module Device intended as an aid in monitoring the DPC's and performance of of IMMULITE IMMULITE 2000 PSA assays.
IMMULITE PSA Control Module is an assayed, tri-level control intended for use with the IMMULITE PSA and IMMULITE 2000 PSA assays. It is intended as an aid in monitoring dayto-day assay performance.

Device Description

Quality Control Material

AI/ML Overview

The provided text is a 510(k) summary for the IMMULITE® PSA Control Module, a quality control material. It does not contain information about acceptance criteria or a study proving performance for a device intended for clinical diagnosis in the way a typical AI/ML device would.

The document states:

  • Device Name: IMMULITE® PSA Control Module
  • Intended Use: An assayed, tri-level control intended for use with the IMMULITE PSA and IMMULITE 2000 PSA assays. It is intended as an aid in monitoring day-to-day assay performance.
  • Clinical Studies: "Not applicable"

Therefore, I cannot extract the specific information requested in your numbered list for an AI/ML device's performance study because the document is about a quality control material, not a diagnostic device that requires such performance criteria and studies. The "study" mentioned is the FDA's review of the 510(k) submission to establish substantial equivalence to a predicate device, not a clinical trial demonstrating diagnostic accuracy.

§ 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.