(32 days)
Not Found
No
The device description and intended use describe a plasma control material for laboratory assays, with no mention of computational analysis or algorithms.
No.
This device is described as a control for quantitative hemostasis assays, indicating it is used for diagnostic accuracy rather than direct treatment or therapy.
No
Explanation: The device, "Reference Check", is described as citrated human plasma used for "controlling the accuracy of quantitative hemostasis assays" and "controlling the following parameters in the normal range". This indicates it's a control or reference material used to ensure the accuracy of assays, rather than a device that directly diagnoses a patient's condition.
No
The device description clearly states that "Reference Check is citrated human plasma collected from 20 or more carefully screened normal donors." This indicates the device is a biological product (plasma control), not a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that "Reference Check is recommended for use in controlling the accuracy of quantitative hemostasis assays." This indicates that the device is used in vitro (outside the body) to evaluate the performance of other diagnostic tests (hemostasis assays).
- Device Description: The device is described as "citrated human plasma," which is a biological sample used in laboratory testing.
- Predicate Device: The mention of a predicate device (K001256; Control Plasma N) strongly suggests that this device falls under the regulatory framework for IVDs, as predicate devices are used to demonstrate substantial equivalence for new IVDs.
The purpose of this device is to serve as a control material for laboratory tests, which is a common function of IVDs used to ensure the reliability and accuracy of diagnostic procedures.
N/A
Intended Use / Indications for Use
Reference Check is recommended for use in controlling the accuracy of quantitative hemostasis assays Reference Check is recommended for use in controlling the following parameters in the normal range:
- Fibrinogen .
- Factor II .
- Factor V .
- Factor VII .
- Factor VIII:C
- vWF: antigen
- vWF: Ristocetin Cofactor
- Factor IX
- Factor X .
- Factor XI .
- Factor XII .
- Factor XIII
- Prekallikrein .
- Protein C: antigen
- Protein C: activity
- Protein S: activity .
- Protein S: total .
- Protein S: free .
- Antithrombin: activity
- Antithrombin: antigen .
- Alpha-2-antiplasmin .
- Plasminogen .
Product codes (comma separated list FDA assigned to the subject device)
GIZ
Device Description
Reference Check is citrated human plasma collected from 20 or more carefully screened normal donors. Plasmas are pooled, buffered using 0.01M HEPES buffer, aliquoted and rapidly frozen.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Control Plasma N (K001256)
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.
Not Found
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).
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.
0
DEC 1 0 2001
510(K) Summary Reference Check
This summary of 510(k) safety and effectiveness information is being submitted in accordance
11 accordance of 510(k) safety and effective a 100 accord and CCCR 007 02 ro(K) Salety and Chock. Choos. Choose of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Submitters Name & Address: | Precision BioLogic Incorporated
900 Windmill Road, Suite 100
Dartmouth, Nova Scotia B3B 1P7
Canada |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Stephen L. Duff – Director of New Business Development
Phone: 902-468-6422 ext. 224
Fax: 902-468-6421
Email: sduff@precisionbiologic.com |
| Preparation Date: | November 7, 2001 |
| Device Name & Classification: | Reference Check
Common Name: Normal Control Plasma
Classification Name: Plasma, Control, Normal
Regulatory Class II, 81 GIZ |
| Predicate Device: | Control Plasma N (K001256)
Dade Behring Inc.
Newark, Delaware 19714
USA |
| Device Description: | Reference Check is citrated human plasma collected from 20 or
more carefully screened normal donors. Plasmas are pooled,
buffered using 0.01M HEPES buffer, aliquoted and rapidly frozen. |
| Device Intended Use: | Reference Check is recommended for use in controlling the
accuracy of quantitative hemostasis assays in the normal range. |
1
Comparison to Predicate Device:
| Parameter | Reference Check | Control Plasma N (K001256) |
|---|---|---|
| Intended Use | Assayed Control - Normal | Assayed Control - Normal |
| Analytes | Fibrinogen, Coagulation factors II, V, | |
| VII, VIII, vWF: Antigen, vWF: Ristocetin | ||
| Cofactor, IX, X, XI, XII, XIII, | ||
| prekallikrein, Protein C (antigen and | ||
| activity), Protein S (activity, total and | ||
| free), antithrombin (antigen and | ||
| activity), Alpha-2 antiplasmin, | ||
| plasminogen | PT, aPTT, TT, Batroxobin time, | |
| Fibrinogen, Coagulation factors, II, V, | ||
| VII, VIII, IX, X, XI, XII, XIII*, VWF | ||
| Ristocetin Cofactor, Antithrombin III, | ||
| Protein C, Protein S*, Alpha-2 | ||
| antiplasmin, C1-inhibitor*, | ||
| Plasminogen, Lupus anticoagulants |
- not available in the US |
| Matrix | Reagent from human plasma (citrated
human plasma collected from 20 or
more carefully screened donors that is
pooled and buffered using HEPES
buffer). | Reagent from human plasma
(obtained from pooled plasma
collected from selected healthy blood
donors and stabilized with HEPES
buffer solution). |
| Format | Frozen | Lyophilized |
| Volume | 1 mL per vial | 1 mL per vial |
Comments on Substantial Equivalence:
It is the opinion of Precision BioLogic Inc. that Reference Check is substantially equivalent to Control Plasma N (K001256), manufactured by Dade Behring Marburg GmbH, and currently marketed in the United States by Dade Behring Inc. This opinion is based on the following:
- . Both products consist of pooled citrated normal human plasma
- Both products are assayed and provide reference ranges for fibrinolytic and . coagulation parameters
- Both products are intended for use in the accuracy and control of assays for . coagulation and fibrinolysis (i.e. hemostasis) in the normal range
Conclusion:
Reference Check is substantially equivalent to Control Plasma N.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract image of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Stephen Duff Director of New Business Development Precision Biologic 900 Windmill Road, Suite 100 Dartmouth, N.S., Canada
DEC 1 0 2001
Re: K013708
Trade/Device Name: Reference Check Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GIZ Dated: November 7, 2001 Received: November 8, 2001
Dear Mr. Duff:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o no re ro rowe 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 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
Indications for Use Statement
510(k) Number:
Device Name:
Reference Check
Indications for Use:
Reference Check is recommended for use in controlling the accuracy of quantitative hemostasis assays Reference Check is recommended for use in controlling the following parameters in the normal range:
- Fibrinogen .
- Factor II .
- Factor V .
- Factor VII .
- Factor VIII:C �
- vWF: antigen ●
- vWF: Ristocetin Cofactor ●
- Factor IX ●
- Factor X .
- Factor XI .
- Factor XII .
- Factor XIII ●
- Prekallikrein .
- Protein C: antigen ●
- Protein C: activity ●
- Protein S: activity .
- Protein S: total .
- Protein S: free .
- Antithrombin: activity ●
- Antithrombin: antigen .
- Alpha-2-antiplasmin .
- Plasminogen .
Josephine Buettner
(Division Syln-Off) (Division of Clinical Laboratory Deving of 510(k) Number ________________________________________________________________________________________________________________________________________________________________