(34 days)
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).
Lyphochek® Coagulation Control is prepared from human plasma, with added purified biochemical and preservatives. The control is provided in lyophilized form for increased stability.
The provided document describes the Bio-Rad Laboratories Lyphochek® Coagulation Control (new device) and its substantial equivalence to a predicate device. The information focuses on the device's characteristics and stability, rather than a clinical study evaluating its performance against specific acceptance criteria for a diagnostic algorithm.
Therefore, the requested information elements related to a study proving the device meets acceptance criteria cannot be fully extracted from this document in the typical sense of an AI/ML device study. However, I can interpret "acceptance criteria" here as the performance specifications the manufacturer claims for the device based on their internal testing (stability studies).
Here's an analysis based on the provided text, addressing the points where information is available and noting when it's not applicable to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Acceptance Criteria) | Reported Device Performance |
|---|---|
| Open Vial Stability (Reconstituted state) | All analytes stable for 24 hours when stored tightly capped at 2-8°C |
| Shelf Life (Unopened, Lyophilized state) | Two years when stored at 2-8°C |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "Stability studies" being performed. This implies internal testing of the manufactured control lots.
- Data Provenance: The studies were performed internally by Bio-Rad Laboratories. The data would be considered prospective for the specific lots tested during the stability studies, but not a "test set" in the context of an AI/ML algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This is not applicable to this type of device. The Lyphochek® Coagulation Control is a quality control material, not a diagnostic device that requires expert interpretation or ground truth establishment in a clinical study setting. The performance is determined by instrumental measurements according to known scientific principles in a laboratory setting.
4. Adjudication Method for the Test Set
- This is not applicable to this type of device. Adjudication methods are relevant for subjective interpretations (e.g., image reading) or complex diagnostic outcomes where multiple experts might disagree.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for comparing the effectiveness of human readers (with vs. without AI assistance) in diagnostic tasks, which is not the function of a coagulation control material.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. The device is a quality control material and does not involve an algorithm that performs a diagnostic task independently.
7. Type of Ground Truth Used
- The "ground truth" for the performance of this control material is based on established analytical methods for coagulation assays (Prothrombin Time, aPTT, Fibrinogen, Antithrombin III, Thrombin Time). The expected values and stability are determined through rigorous laboratory testing using calibrated instruments and reference methods, not expert consensus, pathology, or outcomes data in the usual sense for a diagnostic device.
8. Sample Size for the Training Set
- Not applicable. This device does not use an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device does not use an AI/ML algorithm.
{0}------------------------------------------------
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 RadLyphochek® Coagulation Control(New Device) | Bio RadLyphochek® Coagulation Control(Predicate Device) |
|---|---|---|
| Similarities | ||
| Intended Use | Lyphochek® Coagulation Control isintended for use as a quality controlplasma to monitor the precision of citratedcoagulation systems. | Lyphochek® Coagulation Control isintended for use as a quality controlplasma to monitor the precision of citratedcoagulation systems. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human plasma | Human plasma |
| Storage(Unopened) | 2-8°Cuntil expiration date | 2-8°Cuntil 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 animalorigin | 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
§ 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.