(119 days)
Liquichek Immunoassay Plus Control is intended for use as an assayed quality control serum to monitor the precision of a laboratory testing procedures for the analytes listed in this package insert.
Liquichek Immunoassay Plus 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 quality control device called "Liquichek Immunoassay Plus Control." It does not describe an AI/ML powered medical device, an imaging device, or a device that would typically have acceptance criteria in the manner requested.
Therefore, I cannot provide a response filling out the requested information (acceptance criteria, study details, expert involvement, sample sizes, ground truth, etc.). This document is for a laboratory control product and focuses on its intended use, form, matrix, and storage, and compares it to a substantially equivalent device.
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Image /page/0/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is in black and white, with the words "BIO-RAD" in a bold, sans-serif font. The logo is simple and recognizable. The logo is encased in a rounded rectangle.
Bio-Rad
Laboratories
SEP 16 1988
ECS Division
3726 E. Miraloma Avenue
Anaheim, CA 92806
Telephone (714) 630-6400
Toll Free (800) 854-6737
K 961941
510(k) Summary
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 17, 1996
Device (Trade & Common Name) Liquichek Immunoassay Plus Control
Classification Name CFR 862.1660: Multi-Analyte Controls, All Kinds (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed
Tri-Point Liquimmune Control Medical Analysis Systems, Inc. Camarillo, CA K954322
Statement of Intended Use
Liquichek Immunoassay Plus Control is intended for use as an assayed quality control serum to monitor the precision of a laboratory testing procedures for the analytes listed in this package insert.
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Image /page/0/Picture/16 description: The image contains the number 49 in a bold, sans-serif font. The numbers are black against a white background. The number is slightly off-center to the left.
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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is black and white and features the company name in bold, sans-serif letters. The letters are arranged in a slightly curved line, with the "+" symbol in "BIO+RAD" being slightly larger than the other letters. The logo is enclosed in a rounded rectangle.
Laboratories
ECS Division 3726 E. Miraloma Avenue Anaheim, CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737
Description of the Device
Liquichek Immunoassay Plus 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 Immunoassay Plus Control and the devices to which substantial equivalence is claimed.
| Bio-Rad LiquichekImmunoassay Plus Control | MAS Tri-Point LiquimmuneControl | |
|---|---|---|
| IntendedUse | To monitor the precision of alaboratory testingprocedures for the analyteslisted in the package insert. | A consistent test sample ofknown concentration formonitoring assay conditionsin many immunologicaldeterminations. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| CustomerStorage | 1) -10 to -20°C;2) 30 days at 2-8°C for allanalytes except folate andT3Total which are stable for14 days | 1) 90 Days from receipt at2-8°C |
| Open VialClaim | 14 Days at 2-8°C for allanalytes; except Folatewhich is stable for7 Days at 2-8°C | 30 Days at 2-8°C |
Image /page/1/Picture/8 description: The image contains the number 50. The number is written in a simple, sans-serif font. The number is black and is set against a white background.
§ 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.