(22 days)
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No
The document describes a quality control plasma for laboratory testing and does not mention any AI or ML components.
No
The device is a quality control plasma used to monitor the precision of laboratory testing procedures, not to treat a condition.
No
This device is a quality control plasma used to monitor the precision of laboratory testing procedures, not a device used to diagnose a patient's medical condition.
No
The device description explicitly 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 explicitly states it's "For use as a quality control plasma to monitor the precision of laboratory testing procedures for the analytes listed in this package insert." This clearly 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 a laboratory setting.
- Analytes: The listed analytes are all related to hemostasis (blood clotting), which are common targets for in vitro diagnostic tests.
- Intended User/Care Setting: It's intended for use in a "laboratory," which is the typical setting for IVD testing.
- Predicate Device: The mention of a predicate device (K020878; Lyphocheek Hemostasis Control) strongly suggests that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for demonstrating substantial equivalence in the IVD regulatory pathway.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Lyphochek® Hemostasis Control is intended for use as a quality control plasma to monitor the precision of laboratory analytes listed in the package insert.
For use as a quality control plasma to monitor the precision of laboratory testing procedures for the analytes listed in this package in on the
Analytes listed in the package insert:
- . Antithrombin III (AT III)
- Activated Partial Thromboplastin Time (APTT) .
- D-dimer ◆
- . Factor II
- Factor V .
- Factor VII .
- Factor Vill .
- Factor IX .
- Factor XI .
- Factor XII ◀
- . Fibrinogen
- . Plasminogen
- Protein C (Functional) .
- Protein S (Functional) .
- Prothrombin Time (PT)
- Thrombin Time (TT)
Product codes (comma separated list FDA assigned to the subject device)
GGC, GGN
Device Description
Lyphochek® Hemostasis Control is prepared from human plasma with added purified biochemicals and preservatives. The control is provided in lyophilized form for increased stability.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability studies have been performed to determine the reconstituted stability and shelf life for the Lyphochek® Hemostasis Control. Product claims are as follows:
- Reconstituted Stability: All analytes will be stable for 8 hours at 2 -25°C with the exception of 2.1 Protein S which will be stable for 8 hours at 2 - 8°C.
- 2.2 Shelf Life: Three years when stored at 2 8 °C
- 2.3 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.)
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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.
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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).
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§ 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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Summary of Safety and Effectiveness FEB 2 7 2004 Lyphochek® Hemostasis Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1557 Fax:
Contact Person
Maria Zeballos Requlatory Affairs Specialist (949) 598-1367 Telephone:
Date of Summary Preparation
January 30, 2004
2.0 Device Identification
| Product Trade Name: | Lyphochek® Hemostasis Control |
|---|---|
| Common Name: | Control Plasma Normal and Abnormal |
| Classifications: | Class II |
| Product Code: | GGC |
| Regulation Number: | 21 CFR 864.5425 |
Device to Which Substantial Equivalence is Claimed 3.0
Lyphochek Hemostasis Control Bio-Rad Laboratories Irvine, California
510(k) Number: K020878
Description of Device 4.0
Lyphochek® Hemostasis Control is prepared from human plasma with added purified biochemicals and preservatives. The control is provided in lyophilized form for increased stability.
Statement of Intended Use 5.0
Lyphochek® Hemostasis Control is intended for use as a quality control plasma to monitor the precision of laboratory analytes listed in the package insert.
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Comparison of the new device with the Predicate Device 6.0
Table 1 (below) contains comparison information of similarities and differences between the new Lyphochek Hemostasis Control and the currently marketed Lyphochek Hemostasis Control ((020878) to which substantial equivalence is claimed. The new Lyphochek Hemostasis Control is a tri-level product (Levels 1, 2 and 3) and contains D-dimer. The Lyphochek Hemostasis Control is a bi-levels 1 and 2) product and does not contain D-dimer.
| Characteristics | Bio-Rad
Lyphochek® Hemostasis Control
(New Device) | Bio-Rad
Lyphochek® Hemostasis Control
(Predicate DeviceK020878) |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Lyphochek® Hemostasis Control is intended for use as
a quality control plasma to monitor the precision of
laboratory testing procedures for analytes listed in the
package insert. | Lyphochek® Hemostasis Control is intended for use as a
a quality control plasma to monitor the precision of
laboratory testing procedures for analytes listed in the
package insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human plasma based | Human plasma based |
| Storage (Unopened) | 2-8°C until expiration date | 2-8°C until expiration date |
| Reconstituted Vial
Claim | 8 hours at 2-25°C with the following exception:
Protein S will be stable for 8 hours at 2- 8°C. | 8 hours at 2-25°C with the following exception:
Protein S will be stable for 8 hours at 2- 8°C. |
| Differences | | |
| Levels | Levels 1, 2 and 3 | Levels 1 and 2
Does not contain Level 3 |
| Analytes | Contains: Prothrombin Time (PT), Activated Partial
Thromboplastin Time (APTT), Fibrinogen, Antithrombin
III (AT III) Thrombin Time (TT), Factor II, V, VII, VIII, IX,
X, XI, XII, Protein S (Functional) Protein C (Functional),
Plasminogen and D-dimer | Contains: Prothrombin Time (PT), Activated Partial
Thromboplastin Time (APTT), Fibrinogen, Antithrombin III
(AT III) Thrombin Time (TT), Factor II, V, VII, VIII, IX, X, XI,
XII, Protein S (Functional) and Protein C (Functional),
Plasminogen
Does not Contain: D-dimer |
Table 1. Similarities and Differences between new and predicate device.
7.0 Summary of Performance Data
Stability studies have been performed to determine the reconstituted stability and shelf life for the Lyphochek® Hemostasis Control. Product claims are as follows:
- Reconstituted Stability: All analytes will be stable for 8 hours at 2 -25℃ with the exception of 2.1 Protein S which will be stable for 8 hours at 2 - 8℃.
- 2.2 Shelf Life: Three years when stored at 2 8 °C
- 2.3 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
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
FEB 27 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs/Quality Assurance Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, California 92618-2017
K040275 Rc: Trade/Device Name: Lyphochek Hemostasis Control Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose System for in vitro coagulation studies Regulatory Class: II Product Code: GGN Dated: January 30, 2004 Received: February 5, 2004
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 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 (QS) 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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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,
Joseph L. Arallett
Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices 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): K040275
Device Name: Lyphochek Hemostasis Control
Indications for Use:
For use as a quality control plasma to monitor the precision of laboratory testing procedures for the analytes listed in this package in on the
Analytes listed in the package insert:
- . Antithrombin III (AT III)
- Activated Partial Thromboplastin Time (APTT) .
- D-dimer ◆
- . Factor II
- Factor V .
- Factor VII .
- Factor Vill .
- Factor IX .
- Factor XI .
- Factor XII ◀
- . Fibrinogen
- . Plasminogen
- Protein C (Functional) .
- Protein S (Functional) .
- Prothrombin Time (PT)
- Thrombin Time (TT)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)
510(K)_________________________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use ___ or
Over-the Counter use