(142 days)
The provided text does not contain any K/DEN numbers under the "Reference Device(s)" section. It explicitly states "Reference Device(s)\nNot Found".
No
The description details a chemical assay method (Clauss method) and standard statistical analysis (correlation, regression, CV) for determining fibrinogen levels. There is no mention of AI or ML terms, image processing, or data training/testing sets typically associated with AI/ML devices.
No.
The device is used to determine fibrinogen levels, which is a diagnostic function, not a therapeutic intervention. It helps identify a condition (disseminated intravascular coagulation and primary fibrinolysis) but does not treat it.
Yes
The device is described as a "device used to determine the fibrinogen levels in disseminated intravascular coagulation... and primary fibrinolysis." Determining the level of a substance in the body to identify a condition is a diagnostic function.
No
The device description clearly outlines a chemical assay kit that measures fibrinogen levels through a chemical reaction and subsequent measurement of clotting time, indicating it is a physical reagent-based device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to determine fibrinogen levels in blood samples to aid in the diagnosis of conditions like disseminated intravascular coagulation and primary fibrinolysis. This involves testing a sample taken from the human body.
- Device Description: The description details a method (Clauss method) for measuring a substance (fibrinogen) in a biological sample (diluted plasma). This is a characteristic of an in vitro diagnostic test.
- Performance Studies: The performance studies describe testing the device with samples and comparing the results to an established reagent, which is typical for validating an IVD.
The core function of the device is to analyze a biological sample outside of the body to provide information about a person's health status, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sigma Diagnostics Fibrinogen Kit is a device used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).
Product codes
KQJ
Device Description
Fibrinogen is the plasma protein precursor of fibrin, which when cross-linked, becomes the principal component of the fibrin clot. Thrombin cleaves fibrinogen to form a fibrin monomer. Fibrin monomers aggregate to form the insoluble fibrin polymers. Fibrinogen can be deficient in such conditions as congenital afibrinogenemia, hypofibrinogenemia and in some cases of dysfibrinogenemia. It can also be depressed in a number of disease states such as disseminated intravascular coagulation, systemic fibrinolysis, pancreatitis and severe hepatic dysfunction. Fibrinogen is an acute phase reactant protein whose concentration increases in response to many different physiological stimuli. It can be increased as a response to inflammatory states, with infections, during pregnancy and after trauma. It is elevated among smokers. High fibrinogen levels in plasma have been associated with prethrombotic states. Fibrinogen levels have also been positively correlated to development of atherosclerotic cardiovascular disease and with the occurrence of myocardial infarction and stroke. Because of the increased importance of the assessing fibrinogen levels, a reliable, sensitive procedure is necessary.
The method of Clauss measures the rate of fibrin conversion in the presence of excess thrombin and has been shown to be rapid, sensitive and precise. When diluted plasma is clotted with excess thrombin, the fibrinogen level is inversely proportional to the clotting time, vielding a curvilinear relationship when plotted on loglog paper. A calibration curve prepared from a fibrinogen reference is used to determine the fibrinogen concentration in the test sample.
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)
The safety and effectiveness of Sigma Diagnostics Fibrinogen Determination Kit, Procedure No. 888/887 has been demonstrated by showing its substantial equivalence to Sigma Diagnostics Fibrinogen Determination Kit, Procedure No. 880/881. One hundred two samples having fibrinogen concentrations ranging from 95 to 764 mg/dL were assayed on the Fibrometer with the described reagent (y) and with an established reagent (x). Comparison of the results vielded a correlation coefficient of 0.96 and a regression equation of y = 0.91x + 28.3. Precision studies demonstrated a within-run CV of less than 5% and total precision of 6% or less. The Sigma Diagnostics Fibrinogen Kit, Procedure No. 886/887 has been determined to be linear to 1000 mg/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient of 0.96; regression equation of y = 0.91x + 28.3; within-run CV of less than 5%; total precision of 6% or less; linear to 1000 mg/dL
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7340 Fibrinogen determination system.
(a)
Identification. A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).(b)
Classification. Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
K-11852
- 9 1997 nct
SUMMARY OF SAFETY AND EFFECTIVENESS FIBRINOGEN DETERMINATION KIT (PROC NO. 886/887)
Fibrinogen is the plasma protein precursor of fibrin, which when cross-linked, becomes the principal component of the fibrin clot. Thrombin cleaves fibrinogen to form a fibrin monomer. Fibrin monomers aggregate to form the insoluble fibrin polymers. Fibrinogen can be deficient in such conditions as congenital afibrinogenemia, hypofibrinogenemia and in some cases of dysfibrinogenemia. It can also be depressed in a number of disease states such as disseminated intravascular coagulation, systemic fibrinolysis, pancreatitis and severe hepatic dysfunction. Fibrinogen is an acute phase reactant protein whose concentration increases in response to many different physiological stimuli. It can be increased as a response to inflammatory states, with infections, during pregnancy and after trauma. It is elevated among smokers. 12 High fibrinogen levels in plasma have been associated with prethrombotic states. Fibrinogen levels have also been positively correlated to development of atherosclerotic cardiovascular disease and with the occurrence of myocardial infarction and stroke. 34 Because of the increased importance of the assessing fibrinogen levels, a reliable, sensitive procedure is necessary.
The method of Clauss measures the rate of fibrin conversion in the presence of excess thrombin and has been shown to be rapid, sensitive and precise.57 When diluted plasma is clotted with excess thrombin, the fibrinogen level is inversely proportional to the clotting time, vielding a curvilinear relationship when plotted on loglog paper. A calibration curve prepared from a fibrinogen reference is used to determine the fibrinogen concentration in the test sample.
The safety and effectiveness of Sigma Diagnostics Fibrinogen Determination Kit, Procedure No. 888/887 has been demonstrated by showing its substantial equivalence to Sigma Diagnostics Fibrinogen Determination Kit, Procedure No. 880/881. One hundred two samples having fibrinogen concentrations ranging from 95 to 764 mg/dL were assayed on the Fibrometer with the described reagent (y) and with an established reagent (x). Comparison of the results vielded a correlation coefficient of 0.96 and a regression equation of y = 0.91x + 28.3. Precision studies demonstrated a within-run CV of less than 5% and total precision of 6% or less. The Sigma Diagnostics Fibrinogen Kit, Procedure No. 886/887 has been determined to be linear to 1000 mg/dL.
REFERENCES
- Day HJ, Arkin C F, Bovill EG, Bowie EJW, Carroll JJ, Joist JH, Lenahan JG, 1. Marlar RA, Triplett DA: Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline. NCCLS Document H30-A. Villanova PA: National Committee for Clinical Laboratory Standards; 14(2): 1-13, 1994
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- Tan V, Doyle CJ, Budzynski: Comparison of the Kinetic Fibrinogen Assay With the von Clauss Method and the Clot Recovery Method in Plasma of Patients
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With Conditions Affecting Fibrinogen Coagulability. Am. J. Clin. Pathol. 104:455-462. 1995.
- Kannel WB, Wolf PA, Castelli WP, D'Agostino RB. Fibrinogen and risk of 3. cardiovascular disease: The Framingham Study. JAMA 258:1183-1186, 1987.
- Meade TW. Brozovic M. Chakrabarti RR, Haines AP, Imeson JD, Mellows S. 4. Miller GJ, North WRS, Stirling Y, Thrompson SG: Haemostatic Function and Ischaemic Heart Disease: Principal Results of the Northwick Park Heart Study. Lancet 2:533-537, 1987.
- ട. Clauss. A: Gerinungs physiologische schnell Methods zur bestimmung des Fibrinogens. Acta Haematol 17:237, 1957
- Koepke JA, Gilmer PH, Filip DJ et al: Studies of fibrinogen measurement in the 6. CAP survey program. Am J Clin Pathol 63:984, 1975
- Bovill EG, McDonagh J, Triplett DA, Arkin CF, Brand JT, Hayes TE, Kaczmarek 7. E. Long T. Rock WA: Performance Characteristics of Fibrinogen Assays; Results of the College of American Pathologists Proficiency Testing Program 1988-1991. Arch, Pathol, Lab. Med, 117:58-66, 1993.
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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
William R. Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics® 545 South Ewing Avenue St. Louis, Missouri 63103
Re: K971858 Fibrinogen Kit Trade Name: Regulatory Class: II Product Code: KQJ Dated: Auqust 6, 1997 Received: August 8, 1997
Dear Dr. Gilbert:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
OCT - 9 1997
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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 leqally 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 diaqnostic 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
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): ____________________________________________________________________________________________________________________________________________________
Device Name: __ Sigma Diagnostics Fibrinogen Kit
Indications For Use:
The Sigma Diagnostics Fibrinogen Kit is a device used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) ( Division of Clinical Labor
Division of Clinical Labor
5100) 510(k) Number _
Over-The-Counter Use
Prescription Use ✓
(Per 21 CFR 801.109)
OR