(55 days)
Not Found
No
The summary describes a plasma-based control for lupus anticoagulant assays and does not mention any AI or ML components or functionalities.
No
The device is described as a positive control for assays for lupus anticoagulant, meaning it's used for diagnostic testing rather than directly treating a condition.
No
Explanation: The device is described as a "positive control in assays for lupus anticoagulant." A control is used to verify the performance of a diagnostic assay but is not itself a diagnostic device that directly diagnoses a medical condition in a patient.
No
The device is a biological control material (human plasma) and does not involve any software component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "recommended for use as a positive control in assays for lupus anticoagulant." Assays for lupus anticoagulant are performed in vitro (outside the body) on biological samples (human plasma).
- Device Description: The description details that it is prepared from "human source plasma" and is used in a laboratory setting ("processed in a manner that yields platelet-poor plasmas. Plasma is then buffered, aliquoted and rapidly frozen"). This further supports its use in in vitro testing.
- Predicate Device: The predicate device listed (K952623; CryoCheck Lupus Positive Control) is also an IVD, indicating that this type of product is classified as such.
Therefore, based on the intended use, device description, and predicate device information, the CryoCheck Weak Lupus Positive Control is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CryoCheck Weak Lupus Positive Control is prepared from human source plasma and is recommended for use as a positive control in assays for lupus anticoagulant.
Product codes
GGC
Device Description
CryoCheck Weak Lupus Positive Control contains citrated human plasma collected from donors that have tested positive in accordance with the revised criteria of the SSC Subcommittee for the Standardization of Lupus Anticoagulants. Source plasmas are processed in a manner that yields platelet-poor plasmas. Plasma is then buffered, 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SECTION V
510(K) Summary CryoCheck Weak Lupus Positive Control
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K032804 |
|---|---|
| Submitters Name & Address: | Precision BioLogic Inc. |
| 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 | |
| E-mail: sduff@precisionbiologic.com | |
| Preparation Date: | September 8, 2003 |
| Device Name & Classification: | CryoCheck Weak Lupus Positive Control |
| Common Name: Lupus Positive Control | |
| Classification Name: Plasma, Control, Abnormal | |
| Regulatory Class II, 81 GGC | |
| Predicate Device: | CryoCheck Lupus Positive Control (K952623) |
| Precision BioLogic Inc. | |
| 900 Windmill Road, Suite 100 | |
| Dartmouth, Nova Scotia B3B 1P7 | |
| Canada | |
| Device Description: | CryoCheck Weak Lupus Positive Control contains citrated |
| human plasma collected from donors that have tested positive | |
| in accordance with the revised criteria of the SSC | |
| Subcommittee for the Standardization of Lupus | |
| Anticoagulants. Source plasmas are processed in a manner | |
| that yields platelet-poor plasmas. Plasma is then buffered, | |
| aliquoted and rapidly frozen. | |
| Device Intended Use: | CryoCheck Weak Lupus Positive Control is prepared from |
| human source plasma and is recommended for use as a | |
| positive control in assays for lupus anticoagulant. |
5 Exner T, Triplett DA, Taberner D, Machin SJ. Guidelines for testing and revised criteria for lupus anticoagulant. Thromb Haemost 1991; 65:320-322.
1
Comparison to Predicate Device:
| Parameter | CryoCheck Weak Lupus Positive Control | CryoCheck Lupus Positive Control (K952623) |
|---|---|---|
| Intended Use | Recommended for use as a positive control in | |
| assays for lupus anticoagulant | Recommended for use as a positive control in | |
| assays for lupus anticoagulant | ||
| Matrix | Contains citrated human plasma collected from | |
| donors that have tested positive in accordance | ||
| with the revised criteria of the SSC Subcommittee | ||
| for the Standardization of Lupus Anticoagulants6. | ||
| Source plasmas are processed in a manner that | ||
| yields platelet-poor plasmas. Plasma is then | ||
| buffered, aliquoted and rapidly frozen. | Contains citrated human plasma collected from | |
| donors that have tested positive in accordance | ||
| with the revised criteria of the SSC Subcommittee | ||
| for the Standardization of Lupus Anticoagulants. | ||
| Source plasmas are processed in a manner that | ||
| yields platelet-poor plasmas. Plasma is then | ||
| buffered, aliquoted and rapidly frozen | ||
| Format | Frozen | Frozen |
| Volume | 1. | |
| 0.5 mL per vial |
1.0 mL per vial | 1.
0.5 mL per vial
2.
1.0 mL per vial |
Comments on Substantial Equivalence:
It is the opinion of Precision BioLogic Inc. that CryoCheck Weak Lupus Positive Control is substantially equivalent to CryoCheck Lupus Positive Control (K952623), currently manufactured and marketed in the United States by Precision BioLogic Inc. This opinion is based on the following:
- . Both products consist of human source plasma
- Both products are intended for use a positive control in assays for lupus anticoagulant. .
- . Both products are provided in a frozen format.
Conclusion:
CryoCheck Weak Lupus Positive Control is substantially equivalent to CryoCheck Lupus Positive Control.
6 Exner T, Triplett DA, Taberner D, Machin SJ. Guidelines for testing and revised criteria for lupus anticoagulant. Thromb Haemost 1991; 65:320-322.
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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Stephen L. Duff Director of New Business Development Precision BioLogic Inc. 900 Windmill Road, Suite 100 Dartmouth, Nova Scotia Canada B3B 1P7
NOV - 3 2003
Re: K032804
Trade/Device Name: CryoCheck Weak Lupus Positive Control Regulation Number: 21 CFR § 864.5425 Regulation Name: Plasma, Control, Abnormal Regulatory Class: II Product Code: GGC Dated: September 8, 2003 Received: September 12, 2003
Dear Mr. Duff:
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.
3
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 Putman
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
4
SECTION IV
Indications for Use Statement
| Labels | Values |
|---|---|
| 510(k) Number: | K032804 |
| Device Name: | CryoCheck Weak Lupus Positive Control |
Indications for Use:
CryoCheck Weak Lupus Positive Control is prepared from human source plasma and is recommended for use as a positive control in assays for lupus anticoagulant.
Josephine Bautista
Division Sigh-
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Kd.32894