(119 days)
Dried Rabbit Brain Thromboplastin with Calcium. For use in prothrombin time (PT) determinations and prothrombin time based assays.
Dade® Thromboplastin C Plus is a lyophilized preparation of dried rabbit brain with calcium and stabilizers. The reagent initiates clotting via the extrinsic common pathway in a global screening test, the prothrombin time (PT). The obtained clotting time detects single or combined deficiencies of the extrinsic coagulation system indicative of hereditary and acquired coagulation disorders, is a sensitive monitoring test for oral anticoagulation therapy and an assay for specific coagulation factors.
Here's a summary of the acceptance criteria and study details for the Dade® Thromboplastin C Plus, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Max. Error Criteria %CV" column in the precision study. The device performance (Total %CV) is compared against these maximum allowable values. For the method comparison studies, the "Coefficient of Correlation (r)" values suggest that a strong positive correlation (closer to 1) is desired, though a specific threshold for acceptance isn't explicitly stated. However, given the context of demonstrating substantial equivalence, values close to 1.0 are indicative of good performance.
| Study Type / Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Method Comparison Studies | Implicit: High Coefficient of Correlation (r) | Compared against Multifibren™ U on various analyzers: - BCTTM/BCTTM: r = 0.951 - BCSTM/BCTTM: r = 0.935 - Sysmex® CA-1500/BCT: r = 0.965 - Sysmex® CA-6000/BCT: r = 0.943 - Sysmex® CA-500/BCT: r = 0.975 |
| Precision Study (Derived Fibrinogen) | %CV should be ≤ Max. Error Criteria %CV (10%) | Control Plasma N (CPN): Total %CV = 5.4% (vs. 10% criteria) Control Plasma P (CPP): Total %CV = 1.1% (no criteria specified for this low-level control, but low is good) Normal Plasma Pool (NPP): Total %CV = 4.6% (vs. 10% criteria) Pathological Plasma Pool (PPP): Total %CV = 4.5% (vs. 10% criteria) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the method comparison studies, the sample sizes ranged from 103 to 176 specimens, depending on the analyzer used. For the precision study, each control/plasma pool had 40 replicates (n=40).
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as the device is an in vitro diagnostic (IVD) for laboratory testing, not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for these studies would be the actual fibrinogen concentration or prothrombin time as measured by an established reference method (the predicate device, Multifibren™ U, in the comparison study).
4. Adjudication Method for the Test Set
- Not applicable. As an IVD, an adjudication method by human experts is not typically used for establishing ground truth for chemical/coagulation assays. Ground truth is based on the reference method's results.
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 device is an IVD for prothrombin time and fibrinogen determination, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, a standalone performance study was done. The studies presented (method comparison and precision studies) demonstrate the performance of the Dade® Thromboplastin C Plus reagent in conjunction with automated coagulation analyzers. These are essentially standalone performance evaluations of the reagent and analyzer system.
7. The Type of Ground Truth Used
- For Method Comparison Studies: The ground truth was essentially the measurements obtained using the predicate device, Multifibren™ U. The goal was to show strong correlation and agreement between the new device and the predicate.
- For Precision Studies: The ground truth for calculating variability (%CV) would be the true/reference value of the control plasmas, which are characterized for their expected fibrinogen levels.
8. The Sample Size for the Training Set
- Not applicable. The provided text describes performance validation studies for an IVD reagent. There is no indication of a machine learning model or "training set" in the context of this device's development or regulatory submission.
9. How the Ground Truth for the Training Set was Established
- Not applicable. (See point 8.)
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JAN 1 8 2002
510(k) Summary of Safety and Effectiveness Dade® Thromboplastin C Plus September 20, 2001
Dade Behring Inc. 13251 NW 9th Terrace Miami, FL 33182 Contact Person: Radames Riesgo at 305.480.7558 or by facsimile at 305.552.5288.
| Trade or Proprietary Name: | Dade® Thromboplastin C Plus |
|---|---|
| Common or Usual Name: | Prothrombin time assay |
| Classification Name: | Prothrombin Time Test (21 CFR § 864.7750) |
| Registration Number: | Location |
Manufacturer Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 Marburg, Germany
9610806
Distributor Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, DE 19714-6101
2517506
The modified product is an in vitro diagnostic test for the determination of prothrombin time and prothrombin time-based assays. Dade® Thromboplastin C Plus is a lyophilized preparation of dried rabbit brain with calcium and stabilizers. The reagent initiates clotting via the extrinsic common pathway in a global screening test, the prothrombin time (PT). The obtained clotting time detects single or combined deficiencies of the extrinsic coagulation system indicative of hereditary and acquired coagulation disorders, is a sensitive monitoring test for oral anticoagulation therapy and an assay for specific coagulation factors.
Dade® Thromboplastin C Plus is substantially equivalent in intended use for fibrinogen determination to Multifibren™ U (K934326). Both the proposed product and the predicate device are intended to provide results of the fibrinogen concentration present in citrated human plasma.
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Comparative performance studies involving different photo-optical coagulation analyzers were conducted to evaluate the performance of both reagents for the determination of fibrinogen concentration in specimens.
The results of the performance studies are summarized in the tables below.
| Analyzers | SampleNumber (n) | Coefficient ofCorrelation (r) | RegressionEquation |
|---|---|---|---|
| BCTTM/BCTTM | 171 | 0.951 | Y = 1.03X - 0.40 |
| BCSTM/BCTTM | 165 | 0.935 | Y = 1.09X - 0.59 |
| Sysmex® CA-1500/BCT | 166 | 0.965 | Y = 1.09X - 0.32 |
| Sysmex® CA-6000/BCT | 103 | 0.943 | Y = 1.08X - 0.65 |
| Sysmex® CA-500/BCT | 176 | 0.975 | Y = 1.12X - 0.41 |
Summary of Method Comparison Studies between Dade® Thromboplastin C Plus and Multifibren™ U
Summary of Precision Study Derived Fibrinogen Determination on Sysmex® Automated Coagulation Analyzer CA-1500
| Assay | ControlLevel | n | Mean | WithinRun%CV | BetweenRun%CV | Total%CV | Max.ErrorCriteria%CV |
|---|---|---|---|---|---|---|---|
| Derived Fibrinogen(Dade®Thromboplastin CPlus) | CPN | 40 | 1.8 | 5.5 | 1.6 | 5.4 | 10 |
| CPP | 40 | 0.7 | 1.1 | 0.4 | 1.1 | ||
| NPP | 40 | 2.9 | 4.6 | 1.7 | 4.6 | ||
| PPP | 40 | 4.6 | 4.7 | 1.1 | 4.5 |
CPN: Control Plasma N CPP: Control Plasma P NPP: Normal plasma pool PPP: Pathological plasma pool
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Image /page/2/Picture/0 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of a human figure embracing a bird, symbolizing the department's mission to protect and promote the health and well-being of Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Rebecca S. Ayash Director, Regulatory Affairs and Compliance Dade Behring Inc. Glasgow Site, P.O. Box 6101 Newark, DE 19714-6101
JAN 1 8 2002
Re: K013155
Trade/Device Name: Dade® Thromboplastin C Plus Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: December 13, 2001 Received: December 14, 2001
Dear Ms. Ayash:
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/odrh/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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Korziss 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Dade® Thromboplastin C Plus
Indications for Use:
Dried Rabbit Brain Thromboplastin with Calcium. For use in prothrombin time (PT) determinations and prothrombin time based assays. '
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stephen Bautista
(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K013153
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).