(34 days)
MLA ELECTRA series, Dade BBL Fibrometer
No
The document describes a quality control material for coagulation testing and does not mention any AI or ML components.
No.
This device is a quality control plasma used to monitor the precision of coagulation systems, not to treat or diagnose a patient's condition.
No
This device is described as a "quality control plasma" used to "monitor the precision of citrated coagulation systems," not to diagnose a patient's condition.
No
The device description clearly states it is prepared from human plasma and provided in lyophilized form, 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 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.
- Device Description: It's prepared from human plasma and used in laboratory settings to check the accuracy of coagulation assays like PT, APTT, Fibrinogen, TT, and AT III. These are all in vitro diagnostic tests.
- Predicate Device: The mention of a predicate device (K990858; Lyphochek® Coagulation Control) further confirms its classification as an IVD, as predicate devices are typically other legally marketed IVDs.
The information provided aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. In this case, it's used to monitor the performance of the tests that examine those specimens.
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.
Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen and Antithrombin III (AT III) are assayed on the MLA ELECTRA series. Thrombin Time (TT) is assayed on the Dade BBL Fibrometer (Becton Dickinson).
Product codes
GGN
Device Description
Lyphochek® Coagulation Control is prepared from human plasma, with added purified biochemical 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)
Stability studies have been performed to determine the open vial stability and shelf life for the Lyphochek® Coagulation Control. Product claims are as follows:
- Open vial: Once the control material is reconstituted, all analytes will be stable for 7.1 24 hours when stored tightly capped at 2-8°C
- Shelf Life: Two years when stored at 2-8 °C 7.2
- 7.3 Real time studies will be ongoing to support the shelf life of this product.
All supporting data is retained on file at Bio-Rad Laboratories.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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Page 1 of 2
SEP 1 8 2001
Summary of Safety and Effectiveness Lyphochek® Coagulation Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1555 Fax:
Contact Person
Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367
Date of Summary Preparation
August 15, 2001
2.0 Device Identification
| Product Trade Name: | Lyphochek® Coagulation Control |
|---|---|
| Common Name: | Plasma Coagulation Control |
| Classifications: | Class II |
| Product Code: | GGN |
| Regulation Number: | 21 CFR 864.5425 |
Device to Which Substantial Equivalence is Claimed 3.0
Lyphochek® Coagulation Control Bio-Rad Laboratories Irvine, California
Docket Number: K990858
4.0 Description of Device
Lyphochek® Coagulation Control is prepared from human plasma, with added purified biochemical and preservatives. The control is provided in lyophilized form for increased stability.
5.0 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
Comparison of the new device with the Predicate Device 6.0
The new Lyphochek® Coagulation Control claims substantial equivalence to the Lyphochek® Coagulation Control currently in commercial distribution (K990858). The new Lyphochek® Coagulation Control does not contain constituents of animal origin and the current product does.
| Table 1. Similarities and Differences between new and predicate device. | |
|---|---|
| -- | ------------------------------------------------------------------------- |
| Characteristics | Bio Rad
Lyphochek® Coagulation Control
(New Device) | Bio Rad
Lyphochek® Coagulation Control
(Predicate Device) |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Lyphochek® Coagulation Control is
intended for use as a quality control
plasma to monitor the precision of citrated
coagulation systems. | Lyphochek® Coagulation Control is
intended for use as a quality control
plasma to monitor the precision of citrated
coagulation systems. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human plasma | Human plasma |
| Storage
(Unopened) | 2-8°C
until expiration date | 2-8°C
until expiration date |
| Analytes | Prothrombin Time (PT)
Activated Partial Thromboplastin Time
(APTT), Fibrinogen,
Antithrombin II (AT III)
Thrombin Time (TT) | Prothrombin Time (PT)
Activated Partial Thromboplastin Time
(APTT), Fibrinogen,
Antithrombin II (AT III)
Thrombin Time (TT) |
| Differences | | |
| Open Vial Claim | 24 hours at 2-8°C | 24 hours at 2-25°C |
| Formulation | Does not contain constituents of animal
origin | Contain constituents of animal origin |
| Catalog Number | 781, 782, 783 | 787, 788, 789 |
| Fill size | 1 mL | 2 mL |
7.0 Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Lyphochek® Coagulation Control. Product claims are as follows:
- Open vial: Once the control material is reconstituted, all analytes will be stable for 7.1 24 hours when stored tightly capped at 2-8°C
- Shelf Life: Two years when stored at 2-8 °C 7.2
- 7.3 Real time studies will be ongoing to support the shelf life of this product.
All supporting data is retained on file at Bio-Rad Laboratories.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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 or bird-like figure, with three curved lines representing its body and wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 8 2001
Ms. Elizabeth Platt Regulatory Affairs Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618
Re: K012722
Trade/Device Name: Lyphochek® Coagulation Control Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GGN Dated: August 15, 2001 Received: August 15, 2001
Dear Ms. Platt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -
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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 Butman
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
4
510 (k) Number (if known): K 01 2722
Lyphochek® Coagulation Control Device Name:
Indications for Use:
Lyphochek® Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.
Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen and Antithrombin III (AT III) are assayed on the MLA ELECTRA series. Thrombin Time (TT) is assayed on the Dade BBL Fibrometer (Becton Dickinson).
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prescription use______________________________________________________________________________________________________________________________________________________________
Josephine Battista
Clinical Laboratory Devices
510(k) Number K0/2722