(38 days)
Not Found
No
The 510(k) summary describes a calibrator and control product for a heparin assay, which are chemical reagents used in laboratory testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on stability and recovery compared to a reference standard, typical for calibrator/control products.
No.
This device is an in vitro diagnostic product used for calibration and quality control of assays measuring unfractionated heparin, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Dade Behring Heparin Calibrator is an in vitro diagnostic product." It also mentions its use in calibrating an assay for measuring unfractionated heparin and as quality control materials for the same assay. These functions are characteristic of diagnostic devices.
No
The device description clearly states it is a "lyophilized product prepared from citrated human plasma" and contains "unfractionated heparin." This indicates a physical, biological product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The Dade Behring Heparin Calibrator is an in vitro diagnostic product..."
- "Dade Behring Heparin Controls are in vitro diagnostic products..."
This clearly identifies the device as intended for use in vitro (outside of a living organism) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Dade Behring Heparin Calibrator is an in vitro diagnostic product used to calibrate the Berichrom® Heparin assay for the measurement of unfractionated heparin. Dade Behring Heparin Controls are in vitro diagnostic products intended to be used as assayed, unfractionated heparin quality control materials for the Berichrom® Heparin assay.
Product codes
GIZ
Device Description
Dade Behring Heparin Calibrator and Controls are lyophilized products prepared from citrated human plasma and contain unfractionated heparin from a porcine source. The kit consists of a calibrator and two levels of assayed controls intended to monitor the performance of Berichrom® Heparin reagent when testing for unfractionated heparin using coagulation analyzers.
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Using at least duplicate determinations, reconstituted stability data met the acceptance criteria of recovering within the assigned values when stored for eight (8) hours at 2 to 8°C.
Different dilutions of USP Heparin Sodium Reference Standard were spiked into citrated plasma samples and the heparin recovery evaluated using a calibration curve established using the USP Heparin Sodium Reference Standard. The same samples were then measured using a calibration curve established with the new Heparin calibrator. Results were compared using regression analysis and the following statistics were obtained:
Dade Behring BCS® Analyzer: Y = 1.07 X - 0.01, r = 0.9985
Sysmex® CA-1500 Analyzer: Y = 0.97 X + 0.01, r = 0.9996
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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K04294/
DEC - 2 2004
510(k) Summary Heparin Calibrator and Controls Manufacturer's Name, Address, Telephone, and Contact Person,
Date of Preparation: Dade Behring Inc. Manufacturer: P.O. Box 6101
Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714 Attn: Radames Riesgo Tel: 305.480.7558
October 22, 2004 Preparation date:
2. Device Name/ Classification:
Dade Behring Heparin Calibrator and Controls / Multipurpose system for in vitro coagulation studies, Class II (864.5425)
Newark, Delaware 19714
3. Identification of the Legally Marketed Device:
aca® Heparin Calibrator (K843202)
Ci-Trol® Heparin Controls, Low and High (K812424)
4. Device Description:
Dade Behring Heparin Calibrator and Controls are lyophilized products prepared from citrated human plasma and contain unfractionated heparin from a porcine source. The kit consists of a calibrator and two levels of assayed controls intended to monitor the performance of Berichrom® Heparin reagent when testing for unfractionated heparin using coagulation analyzers.
5. Device Intended Use:
The Dade Behring Heparin Calibrator is an in vitro diagnostic product used to calibrate the Berichrom® Heparin assay for the measurement of unfractionated heparin. Dade Behring Heparin Controls are in vitro diagnostic products intended to be used as assayed, unfractionated heparin quality control materials for the Berichrom® Heparin assay.
6. Medical device to which equivalence is claimed and comparison information:
The Heparin Calibrator is substantially equivalent in intended use to Dade Behring aca® Heparin Calibrator, Level 3 (K843202). The Controls are substantially equivalent to Dade Behring Ci-trol® Heparin Controls, Low and High (K812424).
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7. Device Performance Characteristics:
Using at least duplicate determinations, reconstituted stability data met the acceptance criteria of recovering within the assigned values when stored for eight (8) hours at 2 to 8°C.
Different dilutions of USP Heparin Sodium Reference Standard were spiked into citrated plasma samples and the heparin recovery evaluated using a calibration curve established using the USP Heparin Sodium Reference Standard. The same samples were then measured using a calibration curve established with the new Heparin calibrator. Results were compared using regression analysis and the following statistics were obtained:
| Dade Behring BCS® Analyzer: | $Y = 1.07 X - 0.01, r = 0.9985$ |
|---|---|
| Sysmex® CA-1500 Analyzer: | $Y = 0.97 X + 0.01, r = 0.9996$ |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Radames Riesgo Manager, Regulatory Affairs and Compliance Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714
DEC - 2 2004
K042941 Re:
Trade/Device Name: Dade Behring Heparin Calibrator and Controls Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: GIZ Dated: October 22, 2004 Received: October 25, 2004
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 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Dade Behring Heparin Calibrator and Controls Device Name:
Indications for Use:
Prescription Use
(Part 21 CFR 801 Subpart D)
The Dade Behring Heparin Calibrator is an in vitro diagnostic product used to calibrate the Berichrom® Heparin assay for the measurement of unfractionated heparin. Dade Behring Heparin Controls are in vitro diagnostic products intended to be used as assayed, unfractionated heparin quality control materials for the Berichrom® Heparin assay.
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| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
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AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(21 CFR 801)
510(k) K042941