(29 days)
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No
The document describes a quality control serum for laboratory procedures and does not mention any AI or ML components.
No
The device is a quality control serum used to monitor the precision of laboratory procedures, not to treat a patient.
No
The device is a quality control serum used to monitor the precision of cardiac marker procedures, not to diagnose a patient.
No
The device description explicitly 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 an individual laboratory's specific cardiac marker procedures." This means it's used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: It's a "quality control serum" prepared from biological material (human serum). Quality control materials are a key component of IVD testing to ensure accuracy and reliability.
- Predicate Device: The presence of a predicate device (K903430; Liquichek CK/LD Isoenzyme Control Bio-Rad Laboratories) further supports its classification as an IVD. Predicate devices are legally marketed devices that are substantially equivalent to the new device, and they are typically IVDs themselves.
The information provided clearly indicates that this device is used in a laboratory setting to evaluate the performance of diagnostic tests, which is the core function of an IVD.
N/A
Intended Use / Indications for 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.
Product codes
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Device Description
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.
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. The logo is in white text on a black background. The text is bold and sans-serif. The logo is enclosed in a rounded rectangle.
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 Liquichek
Cardiac Markers Control | Bio-Rad CK/LD Isoenzyme
Control |
|--------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | To monitor the precision of a
laboratories specific cardiac
markers procedures. | To monitor the precision of a
laboratories CK (Creatine
Kinase), LD (Lactate
Dehydrogenase) and serum
protein testing procedures. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Storage | -10 to -20°C | -10 to -20°C |
| Open Vial
Claim | 20 Days at 2-8°C for all
analytes; except Troponin T
which is stable for
10 Days at 2-8°C | 10 Days at 2-8°C |