(37 days)
Not Found
No
The summary describes a quality control plasma product, not a device that processes data or images, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
This device is a quality control plasma used to monitor the precision of coagulation systems, not to treat or diagnose a disease or condition.
No
Explanation: The device is described as a quality control plasma to monitor the precision of citrated coagulation systems. It is used to ensure the accuracy of other diagnostic devices, rather than directly diagnosing a patient's condition.
No
The device description clearly states it is a lyophilized control prepared from human plasma and other biological materials, indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "monitoring 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 components, and it's used as a "quality control plasma." Quality control materials are a fundamental part of IVD testing to ensure the accuracy and reliability of the diagnostic process.
- Predicate Device: The mention of a predicate device (K964963 Lyphochek Coagulation Control) further confirms its classification as an IVD, as predicate devices are typically other legally marketed IVDs.
The information provided aligns perfectly with the definition and characteristics 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 (comma separated list FDA assigned to the subject device)
GGN
Device Description
Lyphochek Coagulation Control is prepared from human plasma with added constituents of animal origin, purified biochemicals and preservatives. 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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, a company that develops and manufactures products for the life science research and clinical diagnostics markets. Above the logo is the date 4/21/99, written in black ink. The BIO-RAD logo is in a bold, sans-serif font, with the words "BIO" and "RAD" separated by a plus sign. The logo is set against a black background.
Bio-Rad Laboratories e (949) 598-
510(k) Summary
Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation March 12, 1999
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 Lyphochek Coagulation Control Bio-Rad Laboratories Irvine, California K964963
Statement of Intended Use
Lyphochek Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.
1
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 in white text on a black background. The text is bold and sans-serif.
boratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Lyphochek Coagulation Control is prepared from human plasma with added constituents of animal origin, purified biochemicals and preservatives. 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 (New Device) | Bio-Rad Lyphochek Coagulation
Control (Substantially Equivalent
Device) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Intended
Use | A quality control plasma to monitor
the precision of citrated coagulation
systems. | A quality control plasma to monitor
the precision of citrated coagulation
systems. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human based control. | Human based control. |
| Storage | 2-8°C | 2-8°C |
| Open Vial
Claim | 24 hours days when stored tightly
capped at 2-25°C. | 24 hours days when stored tightly
capped at 2-25°C. |
| Analytes | Prothrombin Time (PT), Activated
Partial Thromboplastin Time (APTT),
Fibrinogen, Antithrombin III (AT III),
Thrombin Time (TT). | Prothrombin Time (PT), Activated
Partial Thromboplastin Time (APTT),
Fibrinogen. |
2
Premarket Notification Truthful and Accurate Statement
I certify that, in my capacity as Regulatory Affairs Supervisor of Bio-Rad Laboratories, ECS Division, I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.
Cabret Cluft
3/12/55
Date
Elizabeth Platt Regulatory Affairs Supervisor
Date
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, represented by three curved lines.
APR 2 1 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine. California 92618-2017
Re: K990858
Trade Name: Lyphochek Coagulation Control Regulatory Class: II Product Code: GGN Dated: March 31, 1999 Received: April 2, 1999
Dear Ms. Platt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: K990858
Device Name: Lyphochek Coagulation Control
Indications for Use:
Lyphochek Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.
Peter E. Majurin
al Laboratory Devi
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
Prescription Use
OR Over-The Counter Use _