(63 days)
Sigma Diagnostics AUTO D-Dimer Calibrator is a human plasma calibrator that is suitable for use as calibrator for the Sigma Diagnostics AUTO D-Dimer kit Procedure CRS126 for the quantitative determination of fibrin degradation products containing Ddimer in citrated human plasma in D-dimer agglutination assays.
Sigma Diagnostics AUTO D-Dimer Calibrator is a human plasma control that is suitable for use as a calibrator in the Sigma Diagnostics AUTO D-dimer assay. Sigma Diagnostics AUTO D-Dimer Calibrator is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Calibrator is stable for 3 days when stored at 2-8°C and 8 hours when stored at 18-26°C.
The provided text describes a 510(k) summary for the Sigma Diagnostics AUTO D-Dimer Calibrator. It states that the safety and effectiveness of this new calibrator were demonstrated by its substantial equivalence to a previously marketed calibrator (Sigma Diagnostics AUTO D-Dimer Calibrator, Cat. No. A4842, K003267).
However, the document does not provide specific acceptance criteria, a detailed study report with performance metrics, or information about sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies. The 510(k) summary focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone performance study with explicit acceptance criteria and results.
Therefore, I cannot populate the requested table and answer many of the questions based solely on the given text. The text essentially states "it's equivalent to the old one" without detailing the performance data.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS AUTO D-Dimer Calibrator, Cat. No. A7971
Sigma Diagnostics AUTO D-Dimer Calibrator is a human plasma control that is suitable for use as a calibrator in the Sigma Diagnostics AUTO D-dimer assay.
The safety and effectiveness of the Sigma Diagnostics AUTO D-Dimer Calibrator (Cat. No. A 971) has been demonstrated by its substantial equivalence to the Sigma Diagnostics AUTO D-Dimer Calibrator (Cat. No. A4842) marketed as part of the Sigma Diagnostics AUTO D-Dimer kit Procedure No. CRS126 (K003267).
Sigma Diagnostics AUTO D-Dimer Calibrator is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Calibrator is stable for 3 days when stored at 2-8°C and 8 hours when stored at 18-26°C.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 6 2001
William R. Gilbert II, Ph.D. Manager, Scientific Affairs Sigma Diagnostics Inc. 545 South Ewing St. Louis, MO 63103
Re: K013549
Trade/Device Name: Sigma Diagnostics AUTO D-Dimer Calibrator Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: Class II Product Code: DAP Dated: October 10, 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 1 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, (1) 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/cdrb/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
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510(k) Number (if known): _ K0 (354 9
Device Name: Sigma Diagnostics AUTO D-Dimer Calibrator
Indications For Use:
Sigma Diagnostics AUTO D-Dimer Calibrator is a human plasma calibrator that is suitable for use as calibrator for the Sigma Diagnostics AUTO D-Dimer kit Procedure CRS126 for the quantitative determination of fibrin degradation products containing Ddimer in citrated human plasma in D-dimer agglutination assays.
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(Division Sign-Off) (Division Sign-On)
Division of Clinical Laboratory Deviews KO13549 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
OR
§ 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).