(28 days)
Lyphochek® Hemostasis Control is intended for use as a quality control plasma to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Lyphochek® Hemostasis Control is prepared from human plasma with added purified biochemicals and preservatives. The control is provided in lyophilized form for increased stability.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
Acceptance Criteria and Device Performance
The document describes stability studies as the performance data. Regulatory filings for this type of product often focus on demonstrating that the control material remains stable and performs as expected over time, showing "precision" in monitoring laboratory tests. The acceptance criteria aren't explicitly stated as numerical targets in a table, but rather implied through the successful completion of these stability studies to support specific product claims.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reconstituted Stability: Maintain stability for specified time/temperature for all analytes. | All analytes stable for 8 hours at 2°C to 25°C, with Protein S stable for 8 hours at 2°C to 8°C. |
| Shelf Life: Maintain stability for a specified duration under storage conditions. | Three years when stored at 2°C to 8°C. (Real-time studies ongoing to support this claim). |
Study Information
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "stability studies have been performed," but does not provide details on the number of control units tested, or the frequency/duration of testing within the stated stability periods.
- Data Provenance: Not explicitly stated, though it would be from the manufacturer's (Bio-Rad Laboratories) internal testing as implied by "All supporting data is retained on file at Bio-Rad Laboratories." The country of origin of the data is therefore likely USA. The studies are prospective in nature, as they are establishing future shelf-life and reconstituted stability claims.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of study (stability testing of a quality control plasma) does not typically involve human expert adjudication in the same way an image analysis device would. The "ground truth" is established through analytical methods in a laboratory setting, comparing results from the control material to established reference values or predicate device performance. Therefore, no "experts" in the sense of clinicians or radiologists are involved in establishing ground truth for individual data points from the test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert opinion, typically in diagnostic or screening scenarios. For a quality control product's stability study, performance is measured against established analytical methods and specifications, not subjective expert reviews.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a quality control plasma, not an AI diagnostic or assistance tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laboratory reagent (control plasma) and does not involve an algorithm. Its "performance" is its ability to provide consistent and accurate results when used in laboratory instruments to monitor the precision of other assays.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for evaluating the stability and performance of the Lyphochek® Hemostasis Control would be analytical reference values and established performance characteristics of the analytes within the plasma. This means that at specified time points, the levels of PT, APTT, Fibrinogen, etc., are measured using validated laboratory methods, and these measurements are compared against the expected values and acceptable ranges determined during product development and characterization, often with reference to predicate devices.
8. The sample size for the training set:
- Not applicable. This device is a physical control material, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development. Product development and characterization would involve extensive testing, but this is distinct from training a model.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
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Summary of Safety and Effectiveness Lyphochek® Hemostasis Control
APR 1 5 2002
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1555 Fax:
Contact Person
Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367
Date of Summary Preparation
March 15, 2002
2.0 Device Identification
| Product Trade Name: | Lyphochek® Hemostasis Control |
|---|---|
| Common Name: | Control Plasma NormalControl Plasma Abnormal |
| Classifications: | Class II |
| Product Code: | GGC |
| Regulation Number: | 21 CFR 864.5425 |
3.0 Device to Which Substantial Equivalence is Claimed
Coagulation S.A.C Assayed Control 1 Helena Laboratories Beaumont, Texas
Docket Number: K941737
Coaqulation S.A.C Assayed Control 2 Helena Laboratories Beaumont, Texas
Docket Number: K941872
4.0 Description of Device
Lyphochek® Hemostasis Control is prepared from human plasma with added purified biochemicals and preservatives. The control is provided in lyophilized form for increased stability.
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Statement of Intended Use 5.0
Lyphochek® Hemostasis Control is intended for use as a quality control plasma to Eyphooner - Fromootable aboratory analytes listed in the package insert.
Comparison of the new device with the Predicate Device 6.0
Lyphochek® Hemostasis Control claims substantial equivalence to the Coagulation S.A.C Assayed Control 1 and 2 currently in commercial distribution.
| Bio-Rad | Helena Laboratories | Helena Laboratories | |
|---|---|---|---|
| Characteristics | Lyphochek® Hemostasis Control(New Device) | Coagulation S.A.C.-1 AssayedControl 1(Predicate Device - K941737) | Coagulation S.A.C.-2 AssayedControl 2(Predicate Device - K941872). |
| Similarities | |||
| Intended Use | Lyphochek® Hemostasis Controlis intended for use as a qualitycontrol plasma to monitor theprecision of laboratory testingprocedures for analytes listed inthe package insert. | S.A.C.-1 is assayed controlplasma, which may be used inmany facets of testing in thecoagulation laboratory. | S.A.C.-2 is assayed abnormalcontrol plasma, which may beused in many facets of testing inthe coagulation laboratory. |
| Form | Lyophilized | Lyophilized | Lyophilized |
| Matrix | Human plasma based | Human plasma based | Human plasma based |
| Differences | |||
| Storage | 2-8°C | 2-6°C | 2-6°C |
| (Unopened) | Until expiration date | Until expiration date | Until expiration date |
| ReconstitutedVial Claim | 8 hours at 2°C to 25°C with thefollowing exception:Protein S will be stable for 8 hoursat 2°C to 8°C. | 4 hours 2-6°C | 4 hours 2-6°C |
| Analytes | Contains: Prothrombin Time (PT),Activated Partial ThromboplastinTime (APTT), Fibrinogen,Antithrombin III (AT III) ThrombinTime (TT), Factor II, V, VII, VIII, IX,X, XI, XII, Protein S (Functional)and Protein C (Functional),PlasminogenDoes not Contain: Alpha-Antiplasmin, von Willebrand FactorAntigen, Ristocetin cofactor | Contains: Prothrombin Time(PT), Activated PartialThromboplastin Time (APTT),Fibrinogen, Antithrombin III (ATIII), Factor II, V, VII, VIII, IX, X, XI,XII, Total and Free Protein S,Protein C, Plasminogen, vonWillebrand Factor Antigen, Alpha-antiplasmin, Ristocetin cofactorDoes not Contain: ThrombinTime (TT) | Contains: Prothrombin Time(PT), Activated PartialThromboplastin Time (APTT),Fibrinogen, Antithrombin III (ATIII), Factor II, V, VII, VIII, IX, X, XI,XII, Total and Free Protein S,Protein C, Plasminogen,Ristocetin cofactor, Alpha-antiplasmin, Monoclonal FreeProtein S, von Willebrand FactorAntigenDoes not Contain: ThrombinTime (TT) |
| Table 1. Similarities and Differences between new and predicate device. | ||||||
|---|---|---|---|---|---|---|
| -- | ------------------------------------------------------------------------- | -- | -- | -- | -- | -- |
Summary of Performance Data 7.0
Stability studies have been performed to determine the reconstituted stability and shelf life for the Lyphochek® Hemostasis Control. Product claims are as follows:
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- 7.1 Reconstituted Stability: Once the control material is reconstituted, all analytes will be stable for 8 hours at 2°C to 25°C with the exception of Protein S which will be stable for 8 hours at 2ºC to 8ºC.
- Shelf Life: Three years when stored at 2 to 8 °C. 7.2
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/3/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 three human profiles facing right, with flowing lines representing hair or clothing. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 5 2002
Ms. Maria Zeballos Regulatory Affairs Specialist Bio-Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017
Re: K020878
Trade/Device Name: Lyphochek® Hemostasis Control Regulation Number: 21 CFR § 864.5425 Regulation Name: Control Plasma Abnormal Regulatory Class: II Product Code: GGC Dated: March 15, 2002 Received: March 18, 2002
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 11 your de roo 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 or any I 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.
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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 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/cdrl/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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510 (k) Number (if known):
Lyphochek® Hemostasis Control Device Name: Indications for Use:
Lyphochek® Hemostasis Control is intended for use as a quality control plasma to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription use | ✓ | or | Over-the Counter use | |
|---|---|---|---|---|
| ------------------ | --------------------------------------------------- | ---- | ---------------------- | -------------------------------------------------- |
| (Division/Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K020878 |
§ 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.