(22 days)
Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 3 is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in D-dimer assays. Plasma controls are routinely used in the coagulation laboratory as a means of quality control.
Sigma Diagnostics AUTO D-Dimer Control, Level 3 is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Control, Level 3 is stable for 3 days when stored at 2-8°C and 24 hours when stored at 18-26°C.
The provided text is a 510(k) summary for the Sigma Diagnostics AUTO D-Dimer Control, Level 3. This document describes a control product used in laboratory assays, not a diagnostic device that directly measures patient parameters or relies on an algorithm. Therefore, many of the requested categories in the prompt are not applicable to this type of product.
Here's an attempt to answer the questions based on the available information, noting where information is not relevant or not provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Sigma Diagnostics AUTO D-Dimer Control, Level 2, Cat. No. A5217, K003329) | Demonstrated substantial equivalence to the predicate device. The Level 3 control is suitable for use as an elevated (abnormal) control. |
| Stability when reconstituted and stored at 2-8°C | Stable for 3 days |
| Stability when reconstituted and stored at 18-26°C | Stable for 24 hours |
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 focuses on demonstrating substantial equivalence to a predicate device, which for a control product often involves analytical performance testing rather than clinical study data with human patient samples. The control itself is human plasma-based.
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)
Not applicable. For a control product, "ground truth" typically refers to the expected value or range of the control, which is established through analytical testing and characterization against reference methods or the assay it's designed to control. It does not involve expert consensus in the same way a diagnostic imaging device might.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically associated with expert review of complex diagnostic cases, not with the analytical performance assessment of a laboratory control.
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 is a laboratory control product, not an AI-powered diagnostic device, and thus MRMC studies are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component in this product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a control product, the "ground truth" refers to its characterized properties and values, often established through:
- Analytical testing using established reference methods.
- Comparison to existing, legally marketed controls (as implied by substantial equivalence to Level 2 control).
- Quantitative measurements made with the assay the control is designed to monitor.
The document indicates it is a human plasma-based product, and its intended use is as an "abnormal control" (Level 3) with patient citrated plasma in D-dimer assays. This implies its D-dimer level is elevated and characterized accordingly.
8. The sample size for the training set
Not applicable. This is a control product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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NOV 1 5 2001
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS AUTO D-Dimer Control, Level 3, Cat. No. A8221
Image /page/0/Picture/2 description: The image shows text describing Sigma Diagnostics ACCUMARKTM AUTO D-Dimer Control, Level 3. It is a human plasma control suitable for use as an elevated control with patient citrated plasma in the Sigma Diagnostics AUTO D-dimer assay. The text provides information about the product and its intended use. It is a control used in the Sigma Diagnostics AUTO D-dimer assay.
The safety and effectiveness of the Sigma Diagnostics AUTO D-Dimer Control, Level 3 (Cat. No. A8221) has been demonstrated by its substantial equivalence to the Sigma Diagnostics AUTO D-Dimer Control, Level 2 (Cat. No. A5217, K003329).
Sigma Diagnostics AUTO D-Dimer Control, Level 3 is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Control, Level 3 is stable for 3 days when stored at 2-8°C and 24 hours when stored at 18-26°C.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle-like symbol with three stylized profiles facing right, representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
William R. Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics, Inc. 545 South Ewing Avenue St. Louis, Missouri 63103
NOV 1 5 2001
K013545 Re:
Trade Name: Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 3 Regulation Number: 21 CFR § 864.7320 Regulation Name: Fibrinogen/Fibrin Degradation Products Assay Regulatory Class: II Product Code: DAP Dated: October 19, 2001 Received: October 24, 2001
Dear Dr. Gilbert:
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 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.
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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 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): ____________________________________________________________________________________________________________________________________________________
NOV 1 5 200.
Device Name: _Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 3
Indications For Use: NOV 1 5 2001
Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 3 is a human plasma Olgina Diagnootion AS & Come as an abnormal control with patient citrated plasma in Dcontrol that is outlable for assays. Plasma controls are routinely used in the coagulation laboratory as a means of quality control.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Devices sion of Clinical La 510(k) Number -
Image /page/3/Picture/10 description: The image shows the words "Prescription Use" in bold font, followed by a check mark. Below that, the text "(Per 21 CFR 801.109)" is printed in a smaller, regular font. The text indicates that the product is for prescription use only, as defined by the Code of Federal Regulations.
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 864.7320 Fibrinogen/fibrin degradation products assay.
(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).