(33 days)
Not Found
No
The summary describes a laboratory reagent (calibrators) used in a standard assay method (Clauss method) and makes no mention of AI or ML.
No
The device, Fibrinogen Calibrators, is used to prepare reference curves for the assay of fibrinogen. It is a diagnostic tool, not a device intended for treating or preventing a disease or condition.
No
The "Fibrinogen Calibrators" are used to prepare reference curves for an assay, meaning they are a tool used in a diagnostic process, but they do not directly perform a diagnosis themselves. They are calibrators, not a diagnostic device.
No
The device description clearly states that the device is composed of lyophilized calibrators prepared using pooled human plasma, which are physical substances, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the calibrators are used to prepare reference curves for the assay of fibrinogen. This assay is performed in vitro (outside the body) on a biological sample (plasma).
- Device Description: The device is a lyophilized calibrator prepared from human plasma, which is a biological specimen.
- Predicate Device: The mention of a predicate device with the name "Fibrinogen Calibrator Kit" and a K number (K994341) strongly indicates that this type of device is regulated as an IVD by the FDA.
The core function of this device is to provide known reference points for a diagnostic test performed on a biological sample, which is the definition of an in vitro diagnostic product.
N/A
Intended Use / 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.
Product codes
GFX
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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
510(k) Summary Fibrinogen Calibrator Kit
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
| Manufacturer: | Dade Behring Marburg GmbH
Emil-von-Behring Str. 76
35041 Marburg, Germany | SEP 1 9 2007 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Information: | Dade Behring Inc.
Glasgow Site
Bldg. 500, M.S. 514
P.O. Box 6101
Newark, Delaware 19714-6101
Attn: Radames Riesgo
Tel: 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
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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