(29 days)
Liquichek Cardiac Markers Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory's specific cardiac marker procedures.
Liquichek Cardiac Markers Control is prepared from human serum with added constituents of human and non-human origin. The control is provided in liquid form for convenience.
This document is a 510(k) summary for a medical device called "Liquichek Cardiac Markers Control." It is a quality control material used to monitor the precision of laboratory cardiac marker procedures. The document aims to demonstrate substantial equivalence to a previously cleared device, the "Liquichek CK/LD Isoenzyme Control."
Based on the provided text, there is no information available regarding acceptance criteria, device performance metrics, or a study demonstrating that the device meets specific acceptance criteria. This document describes a quality control material, not a diagnostic or therapeutic device whose performance is typically evaluated against clinical endpoints or diagnostic accuracy metrics.
Therefore, I cannot provide the requested information. The document focuses on:
- Device Identification and Classification: Naming the device, its classification, and intended use.
- Substantial Equivalence Claim: Comparing its technological characteristics (intended use, form, matrix, storage, open vial claim) to a predicate device.
- Composition: Stating it's prepared from human serum with human and non-human constituents.
The concept of "acceptance criteria" and "device performance" as typically applied to diagnostic algorithms or medical devices that generate results (e.g., sensitivity, specificity, accuracy) is not directly applicable or discussed in this 510(k) summary for a quality control material.
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Bio-Rad
Laboratories
ECS Division
3726 E. Miraloma Avenue
Anaheim, CA 92806
Telephone (714) 630-6400
Toll Free (800) 854-6737
510(k) Summary
JUN 11 1996
Submitter Bio-Rad Laboratories, ECS Division 3726 E. Miraloma Avenue Anaheim, CA 92806 (714)630-6400 Fax (714)666-1383
Contact Person Elizabeth Platt
Date of Summary Preparation May 8, 1996
Device (Trade & Common Name) Liquichek Cardiac Markers Control
Classification Name CFR 862.1660: Quality Control Material (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Liquichek CK/LD Isoenzyme Control Bio-Rad Laboratories, Anaheim, CA K903430
Statement of Intended Use Liquichek Cardiac Markers Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory's specific cardiac marker procedures.
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Image /page/1/Picture/0 description: The image shows the logo for BIO-RAD. The logo is white text on a black rounded rectangle. The text is in all caps and bolded.
Bio-Rad
Laboratories
ECS Division 3726 E. Miraloma Avenue Anaheim, CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737
Description of the Device
Liquichek Cardiac Markers Control is prepared from human serum with added constituents of human and non-human origin. The control is provided in liquid form for convenience.
Statement of How Technological Characteristics Compare to Substantial Equilavence Device
A table is provided below comparing the similarities between the Bio-Rad Liquichek Cardiac Markers Control and the devices to which substantial equivalence is claimed.
| Bio-Rad LiquichekCardiac Markers Control | Bio-Rad CK/LD IsoenzymeControl | |
|---|---|---|
| IntendedUse | To monitor the precision of alaboratories specific cardiacmarkers procedures. | To monitor the precision of alaboratories CK (CreatineKinase), LD (LactateDehydrogenase) and serumprotein testing procedures. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Storage | -10 to -20°C | -10 to -20°C |
| Open VialClaim | 20 Days at 2-8°C for allanalytes; except Troponin Twhich is stable for10 Days at 2-8°C | 10 Days at 2-8°C |
§ 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.