(55 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device called "CryoCheck Weak Lupus Positive Control." The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for the new device. Therefore, many of the requested sections regarding a study cannot be directly extracted as such a study with detailed performance metrics is not included.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document. The document's purpose is to establish substantial equivalence, not to demonstrate performance against specific quantitative acceptance criteria for the new device itself. The "performance" described is in terms of its characteristics being similar to the predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided. The document does not describe a clinical study or a test set in the traditional sense for evaluating the new device's performance. It states that the device "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." This indicates the source material, but not a separate "test set" for performance evaluation, nor its provenance details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided. As there's no described "test set" for performance evaluation, there's no mention of experts establishing ground truth for such a set. The "ground truth" for the source plasma is implicitly the results of the tests performed on the donors to determine their lupus anticoagulant status, following the SSC Subcommittee's criteria.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. There is no described test set or adjudication method.
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
This information is not applicable/not provided. The device is a "Lupus Positive Control" (a biological reagent), not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study or AI assistance is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. The device is a biological control, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the source plasma used in the device is based on "donors that have tested positive in accordance with the revised criteria of the SSC Subcommittee for the Standardization of Lupus Anticoagulants." This implies a set of established laboratory test results and clinical criteria for diagnosing lupus anticoagulant status.
8. The sample size for the training set
This information is not provided. The concept of a "training set" as understood in machine learning/AI is not applicable to this biological control device.
9. How the ground truth for the training set was established
This information is not provided. As above, the concept of a training set is not applicable. The "ground truth" for the source material refers to the diagnostic criteria for lupus anticoagulants used to select the plasma donors.
Summary of Device and Substantial Equivalence Claim:
The "CryoCheck Weak Lupus Positive Control" is a biological control designed for use in assays for lupus anticoagulant. It is composed of citrated human plasma from donors who have tested positive for lupus anticoagulant according to specific scientific guidelines (SSC Subcommittee criteria). The manufacturer, Precision BioLogic Inc., is seeking 510(k) clearance by demonstrating substantial equivalence to their previously cleared device, the "CryoCheck Lupus Positive Control (K952623)."
The claim of substantial equivalence is based on the following similarities:
- Intended Use: Both devices are recommended as positive controls in assays for lupus anticoagulant.
- Matrix: Both consist of citrated human plasma from donors testing positive for lupus anticoagulant based on the same SSC Subcommittee criteria.
- Format: Both are provided in a frozen format.
- Volume: Both are available in 0.5 mL and 1.0 mL vial sizes.
The FDA reviewed these similarities and concluded that the new device is substantially equivalent to the predicate device. This means that the new device does not require new efficacy or performance studies to prove its safety and effectiveness, as its characteristics are considered sufficiently similar to an already approved device. The regulatory approval is for the device itself as a control material, not for a diagnostic test utilizing the control, nor an AI algorithm.
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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 100Dartmouth, Nova Scotia B3B 1P7Canada |
| Contact Name: | Stephen L. Duff - Director of New Business DevelopmentPhone: 902-468-6422 ext. 224Fax: 902-468-6421E-mail: sduff@precisionbiologic.com |
| Preparation Date: | September 8, 2003 |
| Device Name & Classification: | CryoCheck Weak Lupus Positive ControlCommon Name: Lupus Positive ControlClassification Name: Plasma, Control, AbnormalRegulatory Class II, 81 GGC |
| Predicate Device: | CryoCheck Lupus Positive Control (K952623)Precision BioLogic Inc.900 Windmill Road, Suite 100Dartmouth, Nova Scotia B3B 1P7Canada |
| Device Description: | CryoCheck Weak Lupus Positive Control contains citratedhuman plasma collected from donors that have tested positivein accordance with the revised criteria of the SSCSubcommittee for the Standardization of LupusAnticoagulants. Source plasmas are processed in a mannerthat yields platelet-poor plasmas. Plasma is then buffered,aliquoted and rapidly frozen. |
| Device Intended Use: | CryoCheck Weak Lupus Positive Control is prepared fromhuman source plasma and is recommended for use as apositive 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.
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Comparison to Predicate Device:
| Parameter | CryoCheck Weak Lupus Positive Control | CryoCheck Lupus Positive Control (K952623) |
|---|---|---|
| Intended Use | Recommended for use as a positive control inassays for lupus anticoagulant | Recommended for use as a positive control inassays for lupus anticoagulant |
| Matrix | Contains citrated human plasma collected fromdonors that have tested positive in accordancewith the revised criteria of the SSC Subcommitteefor the Standardization of Lupus Anticoagulants6.Source plasmas are processed in a manner thatyields platelet-poor plasmas. Plasma is thenbuffered, aliquoted and rapidly frozen. | Contains citrated human plasma collected fromdonors that have tested positive in accordancewith the revised criteria of the SSC Subcommitteefor the Standardization of Lupus Anticoagulants.Source plasmas are processed in a manner thatyields platelet-poor plasmas. Plasma is thenbuffered, aliquoted and rapidly frozen |
| Format | Frozen | Frozen |
| Volume | 1.0.5 mL per vial2.1.0 mL per vial | 1.0.5 mL per vial2.1.0 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.
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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 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.
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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 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
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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
§ 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.