(23 days)
Lyphochek® Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.
Lyphochek® Coagulation Control is prepared from human plasma, with added purified biochemicals (tissue extract from animal origin), and preservatives. The control is provided in lyophilized form for increased stability.
Here's a breakdown of the acceptance criteria and the study details for the Lyphochek® Coagulation Control Level 4, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Product Claim) | Reported Device Performance |
|---|---|
| Open Vial Stability: All analytes stable for 24 hours at 2-25°C | Implied to meet this criterion for all analytes (Studies performed, data on file) |
| Shelf Life: Three years when stored at 2-8°C | Three years when stored at 2-8°C |
Note: The document states that stability studies were performed to determine these claims, and all supporting data is retained on file at Bio-Rad Laboratories. It does not explicitly present a table comparing measured values against a predefined acceptable range, but rather asserts that the product meets these stability claims based on the studies.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the stability studies. It only mentions that "Stability studies have been performed."
Regarding data provenance:
- Country of Origin: Not specified in the provided document.
- Retrospective or Prospective: Not specified, but stability studies are typically prospective, involving monitoring the product over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device (quality control plasma). The "ground truth" for a coagulation control is its inherent stability and performance characteristics, which are determined through laboratory testing using various coagulation systems, not through expert consensus or interpretation of images/data by human experts.
4. Adjudication Method
This information is not applicable to this type of device. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, where multiple reviewers' opinions need to be reconciled (e.g., in medical image analysis).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed and is not applicable to this device. This type of study assesses how human readers' performance changes with AI assistance, which is irrelevant for a laboratory reagent like a coagulation control.
6. Standalone Performance Study
A standalone performance study (algorithm only without human-in-the-loop performance) was not explicitly detailed as such, but the stability studies performed on the Lyphochek® Coagulation Control Level 4 represent its "standalone" performance. The device itself is a control material, and its performance is evaluated directly through laboratory testing using established coagulation methods (PT, APTT, Fibrinogen, AT III, TT), not through an algorithm or human-in-the-loop assessment.
7. Type of Ground Truth Used
The ground truth used for evaluating the device would be the measured values of the coagulation analytes (Prothrombin Time, Activated Partial Thromboplastin Time, Fibrinogen, Antithrombin III, Thrombin Time) over time, compared against expected ranges or reference values for a stable product. This is essentially laboratory test results and established analytical methods.
8. Sample Size for the Training Set
This information is not applicable. This device is a biochemical reagent, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
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SEP 17 2003
Page 1 of 2
Summary of Safety and Effectiveness Lyphochek® Coagulation Control Level 4
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1555
Contact Person
Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367
Date of Summary Preparation
August 11, 2003
2.0 Device Identification
| Product Trade Name: | Lyphochek® Coagulation Control Level 4 |
|---|---|
| Common Name: | Plasma Coagulation Control |
| Classifications: | Class II |
| Product Code: | GGN |
| Regulation Number: | 21 CFR 864.5425 |
3.0 Device to Which Substantial Equivalence is Claimed
Lyphochek® Coagulation Control Bio-Rad Laboratories Irvine, California
Docket Number: K012722
4.0 Description of Device
Lyphochek® Coagulation Control is prepared from human plasma, with added purified biochemicals (tissue extract from animal origin), 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
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6.0 Comparison of the new device with the Predicate Device
The new Lyphochek® Coagulation Control Level 4 claims substantial equivalence to the Lyphochek® Coaqulation Control currently in commercial distribution (K012722). The new Lyphochek® Coagulation Control is a tri-level (Level 1, 2 and 3) product and the current product is a single level (Level 4) product.
| Bio-Rad | Bio-Rad | |
|---|---|---|
| Characteristics | Lyphochek® Coagulation Control | Lyphochek® Coagulation Control |
| (Predicate Device K012722) | (New Device) | |
| Similarities | ||
| Intended Use | Lyphochek® Coagulation Control is intended foruse as a quality control plasma control to monitorthe precision of citrated coagulation systems. | Lyphochek® Coagulation Control is intended foruse as a quality control plasma control to monitorthe precision of citrated coagulation systems. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human plasma | Human plasma |
| Open Vial stability | 24 hours at 2 to 25°C | 24 hours at 2 to 25°C |
| Storage(Unopened) | 2 to 8°CUntil expiration date | 2 to 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) |
| Fill size | 1 mL | 1 mL |
| Differences | ||
| Formulation | Does not contain constituents of animal origin | Contain constituents of animal origin |
| Levels | Levels 1, 2 and 3 (Does not include level 4) | Level 4 (Does not include levels 1, 2 or 3) |
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 Level 4. Product claims are as follows:
- 7.1 Open vial: Once the control material is reconstituted, all analytes will be stable for 24 hours when stored tightly capped at 2-25°C
- 7.2 Shelf Life: Three years when stored at 2-8 °C
- 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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SEP 1 7 2003
ood and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Maria Zeballos Regulatory Affairs Specialist Bio-Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017
Re: K032611 Trade/Device Name: Lyphochek® Coagulation Control Level 4
Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose System for In Vitro Coagulation Studies Regulatory Class: II Product Code: GGN Dated: August 11, 2003 Received: August 25, 2003
Dear Ms. Zeballos:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
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Page 2 -
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Lyphochek® Coagulation Control Level 4 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.
Methods:
- Diagnostica Stago Neoplastine C1 Plus (PT) ●
- Diagnostica Stago PTT Automate .
- Diagnostica Stago Fibrinogen .
- Diagnostica Stago Stachrom (AT III) ●
- Diagnostica Stago Thrombin .
- Axis Shield Nycotest ●
- Axis Shield Cephotest ●
Tugl
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092611
(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription use | or |
|---|---|
| ------------------ | ---- |
Over-the Counter use _________________________________________________________________________________________________________________________________________________________
§ 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.