(22 days)
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No
The document describes a human plasma control for a diagnostic assay, with no mention of AI or ML technology in its function or description.
No.
This device is a control used in diagnostic assays ("human plasma control...for use as an abnormal control with patient citrated plasma in D-dimer agglutination assays") for quality control purposes, not for treating a disease or condition.
No
This device is a control used in D-dimer agglutination assays for quality control purposes in a coagulation laboratory, not a diagnostic device itself.
No
The device is a human plasma control, which is a physical substance used in laboratory testing, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is a "human plasma control that is suitable for use as an abnormal control with patient citrated plasma in Ddimer agglutination assays." This indicates it is used in vitro (outside the body) to analyze a human sample (plasma) for diagnostic purposes (quality control in D-dimer assays).
- Device Description: It is a "human plasma based product" used in the "Sigma Diagnostics AUTO D-dimer assay." This further confirms its use in an in vitro diagnostic test.
- Care Setting: It is intended for use in a "coagulation laboratory," which is a typical setting for in vitro diagnostic testing.
- Predicate Device: The predicate device listed (K003329; Sigma Diagnostics AUTO D-Dimer Control, Level 2) is also an IVD. This suggests the current device is a modification or update of an existing IVD.
The core function of this device is to serve as a quality control material for an in vitro diagnostic test (D-dimer assay) performed on a human sample (plasma). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in D-dimer agglutination assays. Plasma controls are routinely used in the coagulation laboratory as a means of quality control.
Product codes (comma separated list FDA assigned to the subject device)
DAP
Device Description
Sigma Diagnostics AUTO D-Dimer Control, Level 2 is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Control, Level 2 is stable for 3 days when stored at 2-8°C and 24 hours when stored at 18-26°C.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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).
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS NOV 1 5 2001 AUTO D-Dimer Control, Level 2, Cat. No. A8096
Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 is a human plasma control that is suitable for use as a elevated control with patient citrated plasma in the Sigma Diagnostics AUTO D-dimer assay.
The safety and effectiveness of the Sigma Diagnostics AUTO D-Dimer Control, Level 2 (Cat. No. A8096) 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 2 is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Control, Level 2 is stable for 3 days when stored at 2-8°C and 24 hours when stored at 18-26°C.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with wavy lines extending from the bottom of the profiles.
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
K013544 Re:
Trade Name: Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 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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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 nonthoution. The I Drivinessification 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 additionally 60711 . 1011 . 10 - questions on the promotion and advertising of your device, (201) 59 retect 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 miorination on Jour responser 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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Page_1__of_1__
510(k) Number (if known): _| 0135 44
NOV 1 5 2001 Device Name: _ Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2
Indications For Use:
Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in Ddimer agglutination 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)
Torphine Bautista
(Division Sigil-Off) Division of Climical Lationatory Siguiless 510(k) Number -
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________