(71 days)
No
The document describes a quality control plasma for coagulation systems and makes no mention of AI or ML.
No
Explanation: The device is a quality control plasma used to monitor the precision of coagulation systems, not to treat or diagnose a medical condition in a patient.
No
The device is described as a quality control plasma to monitor the precision of coagulation systems, not to diagnose a patient's medical condition. It's used for quality control, not for directly diagnosing disease.
No
The device description clearly states it is a physical product (lyophilized human plasma with added constituents) and not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "use as a quality control plasma to monitor the precision of citrated coagulation systems." This indicates it's used in vitro (outside the body) to assess the performance of diagnostic tests related to blood coagulation.
- Device Description: The description mentions it's prepared from human plasma and other constituents, and it's used in a laboratory setting ("citrated coagulation systems").
- Predicate Device: The predicate device listed (K820450 ThromboScreen Coagulation Control Plasma) is also a coagulation control plasma, which falls under the category of IVD devices.
Therefore, based on the provided information, the Lyphochek Coagulation Control fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Lyphochek Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.
Product codes
81GGN
Device Description
Lyphochek Coagulation Control is prepared from human plasma with added constituents of non-human origin and purified biochemicals. The control is provided in lyophilized form for increased stability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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Image /page/0/Picture/0 description: The image shows the logo for Bio-Rad. The logo is white text on a black background. The text is bold and sans-serif.
Bio-Rad
Laboratories
ECS Division
3726 E. Miraloma Avenue
Anaheim, CA 92806
Telephone (714) 630-6400
Toll Free (800) 854-6737
FEB 20 1997
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 November 27, 1996
Device (Trade & Common Name) Lyphochek Coagulation Control
Classification Name Class II, 81GGN CFR 864.5425: Plasma Coagulation Control
Devices to Which Substantial Equivalence is Claimed ThromboScreen Coagulation Control Plasma Pacific Hemostasis K820450
Statement of Intended Use Lyphochek Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.
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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 "BIO-RAD" with a plus sign between "BIO" and "RAD".
Bio-Rad
Laboratories
ECS Division 3726 E. Miraloma Avenue naheim, CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737
Description of the Device
Lyphochek Coagulation Control is prepared from human plasma with added constituents of non-human origin and purified biochemicals. The control is provided in lyophilized form for increased stability.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Bio-Rad Lyphochek Coagulation Control and the devices to which substantial equivalence is claimed.
| | Bio-Rad Lyphochek
Coagulation Control | Pacific Hemostasis
ThromboScreen Coagulation
Control Plasma |
|-----------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Intended
Use | A quality control plasma to
monitor the precision of
citrated coagulation
systems. | A control in prothrombin time
and partial thromboplastin
time determinations |
| Form | Lyophilized | Lyophilized |
| Matrix | Human plasma | Human Plasma |
| Storage | 2 - 8°C | 2 - 8°C |
| Open Vial | 16 hours at 2-25°C | 8 hours at 2-8°C |
| Claim | | |
| Levels | Level 1, 2 and 3 | Level 1, 2 and 3 |
| Assays | prothrombin time (PT),
activated partial
thromboplastin time (APTT),
fibrinogen (Level 1) | prothrombin time (PT),
activated partial
thromboplastin time (APTT),
fibrinogen (Level 1) |