(71 days)
Not Found
No
The summary describes a laboratory calibrator for a fibrinogen assay, which is a chemical reagent, not a software or imaging device typically associated with AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is described as "Fibrinogen Calibrators" used to prepare reference curves for an assay, not for treating any condition.
No
The device is a calibrator used to prepare reference curves for an assay, not a device that directly diagnoses a condition.
No
The device description clearly states the device is "lyophilized calibrators prepared from pooled human plasma," indicating it is a physical substance, 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 "for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibrin U." This describes a test performed in vitro (outside the body) on a biological sample (presumably plasma, as the calibrators are prepared from human plasma) to measure a specific analyte (fibrinogen).
- Device Description: The description confirms that the calibrators are "lyophilized calibrators prepared from pooled human plasma... diluted with buffered solution or supplemented with purified fibrinogen and stabilized." This further supports the idea that these are reagents used in a laboratory setting for diagnostic testing.
- Predicate Device: The mention of a predicate device (K925988; Dade Behring Fibrinogen Standards) which is also a fibrinogen standard, strongly suggests that this device falls under the same regulatory category, which for such products is typically IVD.
The information provided clearly indicates that this device is a reagent used in an in vitro test to aid in the diagnosis or monitoring of a medical condition (related to fibrinogen levels).
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 Multifibrin U.
Product codes (comma separated list FDA assigned to the subject device)
GFX
Device Description
The Fibrinogen Calibrators are lyophilized calibrators prepared from pooled human plasma from selected, healthy donors, diluted with buffered 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): 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.
Not Found
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).
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
Dade Behring Inc. Fibrinogen Calibrator Kit 510(k) Notification
MAR - 3 2000
510(k) Summary for Fibrinogen Calibrator Kit
- Manufacture's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
| Manufacturer: | Dade Behring Marburg GmbH
Emil-von-Behring Str. 76
Marburg/Germany |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Dade Behring Inc.
Glasgow Site
P.O. Box 6101
Newark, Delaware 19714
Attn: Rebecca S. Ayash
Tel: 302-631-6276 |
| Preparation date: | December 22, 1999 |
| Device Name Classifications | |
2. Device Name/ Classification:
Fibrinogen Calibrator Kit: Fibrinogen Calibrators
Class II (864.7340) Classification Number:
Identification of the Legally Marketed Device: 3.
Dade Behring Fibrinogen Standards (K925988)
4. Device Description:
The Fibrinogen Calibrators are lyophilized calibrators prepared from pooled human plasma from selected, healthy donors, diluted with buffered solution or supplemented with purified fibrinogen and stabilized.
ર. 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 Multifibrin U.
Medical device to which equivalence is claimed and comparison information: 6.
There are a number of in vitro diagnostic products in commercial distribution, which are used for the establishment of reference curves. One such product is the Dade Behring Fibrinogen Standards (K925988). The Fibrinogen Calibrator Kit is substantially equivalent in intended use to the Fibrinogen Standards. The Fibrinogen Calibrator Kit, like the Fibrinogen Standards is intended to be used for the calibration of a fibrinogen 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.
MAR - 3 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Rebecca S. Ayash Manager, Regulatory Affairs, Biology Dade Behring Glasgow Site P.O. Box 6101 Newark, Delaware 19714
Re: K994341 Trade Name: Fibrinogen Calibrator Kit Regulatory Class: II Product Code: GFX Dated: February 18, 2000 Received: February 24, 2000
Dear Ms. Ayash:
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 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). 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 (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 requirements, as set forth in the Quality System Regulation (OS) 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 regulation 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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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 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 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
3
Dade Behring Inc. Fibrinogen Calibrator Kit 510(k) Notification
Indications for Use Statement
Fibrinogen Calibrator Kit Device Name:
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 Multifibrin U.
ion Sign-Off Division of Clinical Laboratory Devi 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter-Use (Optional Format 1-2-96)
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