(33 days)
Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibren™ U.
The Fibrinogen Calibrators are lyophilized calibrators prepared using pooled human plasma from selected, healthy donors that has been diluted with buffer solution or supplemented with purified fibrinogen and stabilized.
The provided document describes a 510(k) premarket notification for a Fibrinogen Calibrator Kit, which is a device used to calibrate fibrinogen assays. This type of device is an in-vitro diagnostic (IVD) product and its performance evaluation typically focuses on analytical characteristics rather than human-in-the-loop or AI-related metrics. Therefore, several of the requested sections (e.g., MRMC studies, AI improvement, expert ground truth, training set size) are not applicable to this specific device evaluation. The information provided heavily emphasizes the substantial equivalence to a predicate device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative table format. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (Fibrinogen Calibrator Kit K994341) in terms of "intended use and performance." This implies that the performance of the new device is expected to be comparable to or within acceptable variations of the predicate device's established performance. The document doesn't provide specific performance metrics or data in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative criteria in this summary document. | The device is deemed "substantially equivalent in intended use and performance to the Fibrinogen Calibrator Kit (K994341)." This implies its performance is comparable to the predicate device, but specific metrics are not detailed in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not provide details on the sample size used for any testing or the data provenance (e.g., country of origin, retrospective/prospective). Evaluations for calibrators typically involve testing across a range of concentrations and multiple lots, but this information is absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in-vitro diagnostic calibrator, not an AI or imaging device that requires human expert interpretation for establishing ground truth on a test set. Its "ground truth" relates to the accuracy and precision of its calibration values, which would be determined through analytical methods and reference materials.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is not an AI-assisted diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical calibrator kit, not an algorithm. However, the performance assessment would effectively be "standalone" in that it directly evaluates the calibrator's characteristics without a human-in-the-loop component in the evaluation itself.
7. The Type of Ground Truth Used
The "ground truth" for a calibrator refers to its assigned values being accurate and traceable to higher-order reference materials or methods. The summary states the calibrators are "prepared using pooled human plasma from selected, healthy donors that has been diluted with buffer solution or supplemented with purified fibrinogen and stabilized." The establishment of the specific calibration values (the "ground truth" for the calibrator levels) would be based on analytical methods and certified reference materials, but the details are not provided in this summary.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
{0}------------------------------------------------
510(k) Summary Fibrinogen Calibrator Kit
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
| Manufacturer: | Dade Behring Marburg GmbHEmil-von-Behring Str. 7635041 Marburg, Germany | SEP 1 9 2007 |
|---|---|---|
| Contact Information: | Dade Behring Inc.Glasgow SiteBldg. 500, M.S. 514P.O. Box 6101Newark, Delaware 19714-6101Attn: Radames RiesgoTel: 305.480.7558 | |
| Preparation date: | August 16, 2007 |
2. Device Name/ Classification:
Fibrinogen Calibrator Kit / Fibrinogen determination system, Class II (864.7340)
3. Identification of the Legally Marketed Device;
Fibrinogen Calibrator Kit (K994341)
4. Device Description:
The Fibrinogen Calibrators are lyophilized calibrators prepared using pooled human plasma from selected, healthy donors that has been diluted with buffer solution or supplemented with purified fibrinogen and stabilized.
5. Device Intended Use:
Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibren™ U.
Medical device to which equivalence is claimed and comparison 6. information:
The modified Fibrinogen Calibrator Kit is substantially equivalent in intended use and performance to the Fibrinogen Calibrator Kit (K994341) currently marketed. Both devices are intended for use as calibrators for fibrinogen determination using the Dade Behring Multifibren™ U assay.
{1}------------------------------------------------
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Radames Riesgo Regulatory Affairs & Compliance Manager Dade Behring, Inc. P.O. Box 6101 Building 500 MS 514 Newark, Delaware 19714
SEP 1 9 2007
Re: K072304
Trade/Device Name: Fibrinogen Calibrator Kit Regulation Number: 21 CFR 864.7340 Regulation Name: Fibrinogen determination system Regulatory Class: Class II Product Code: GFX Dated: August 16, 2007 Received: August 17, 2007
Dear Mr. Riesgo:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket
{2}------------------------------------------------
Page 2 - Radames Riesgo
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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical-Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert L. Becker, MD, PhD
Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Dade Behring Inc. 510(k) Premarket Notification Fibrinogen Calibrator Kit
Indications for Use Statement
510(k) Number (if known):
Device Name: Fibrinogen Calibrator Kit
Indications for Use:
Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibren™ U.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
ughim Santude
Division Sign Of
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072304
§ 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.