(119 days)
No
The document describes a quality control serum for laboratory testing, with no mention of AI or ML in the intended use, device description, or any other section.
No
Explanation: This device is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures, not to directly treat or diagnose a patient.
No
The device is a quality control serum used to monitor the precision of laboratory testing procedures, not to diagnose a disease or condition in a patient.
No
The device description clearly states it is a liquid control serum prepared from human serum with added constituents, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the precision of a laboratory testing procedures for the analytes listed in this package insert." This is a classic function of an IVD - to ensure the accuracy and reliability of diagnostic tests performed in a laboratory setting.
- Device Description: It's a "quality control serum" used in "laboratory testing procedures." Quality control materials are essential components of IVD testing workflows.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K954322) indicates that this device has gone through a regulatory clearance process, which is required for IVDs. The predicate device, "Tri-Point Liquimmune Control," also sounds like a quality control material used in immunoassay testing, further supporting the IVD classification.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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.
Image /page/0/Picture/15 description: The image shows a black circle at the top of the frame. The rest of the image is white. The black circle is not a perfect circle, as the top is cut off by the edge of the frame.
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 Liquichek
Immunoassay Plus Control | MAS Tri-Point Liquimmune
Control |
|---------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | To monitor the precision of a
laboratory testing
procedures for the analytes
listed in the package insert. | A consistent test sample of
known concentration for
monitoring assay conditions
in many immunological
determinations. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Customer
Storage | 1) -10 to -20°C;
2) 30 days at 2-8°C for all
analytes except folate and
T3Total which are stable for
14 days | 1) 90 Days from receipt at
2-8°C |
| Open Vial
Claim | 14 Days at 2-8°C for all
analytes; except Folate
which is stable for
7 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.