(90 days)
Not Found
No
The device description and intended use are for calibrators and controls for a heparin assay, which are chemical reagents and not software or systems that would typically incorporate AI/ML. There is no mention of AI, ML, or related concepts in the provided text.
No
These devices are in vitro diagnostic products used for calibration and quality control of assays that measure unfractionated heparin, not for direct therapeutic intervention on a patient.
No
The device is a calibrator and control material for an in vitro diagnostic assay, not the diagnostic device itself.
No
The device description clearly states that the products are lyophilized materials containing biological components (heparin and human plasma) that require reconstitution. This indicates a physical, in vitro diagnostic product, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states that the products are "in vitro diagnostic product used for the calibration of the Berichrom Heparin assay for measurement of unfractionated (UF) heparin" and "quality control material for assessment of precision and analytical bias in the quantitative determination of unfractionated (UF) heparin with the Berichrom Heparin assay." This clearly indicates their use in testing biological samples outside of the body to provide information for diagnostic purposes.
- Device Description: The description details the composition of the products (lyophilized unfractionated heparin and buffered human plasma) and how they are used (reconstitution with water). This aligns with the nature of reagents and controls used in in vitro diagnostic assays.
- Predicate Device: The mention of a predicate device (K042941 - Dade Behring Heparin Calibrator and Controls) which is also an IVD further supports the classification of this device as an IVD.
Therefore, the information provided strongly indicates that this device is intended for and functions as an In Vitro Diagnostic product.
N/A
Intended Use / Indications for Use
- Berichrom Heparin UF Calibrator: "For the callbration of the Berichrom Heparin assay for measurement of unfractionated (UF) heparın" and "Berichrom Heparin UF Calibrator is an in vitro diagnostic product used for the calıbration of the Berichrom Heparın assay for measurement of unfractionated (UF) heparın"
- Berichrom Heparin UF Control 1: "For use as a low level assayed control for the quantitative measurement of unfractionated (UF) heparin with the Benchrom Heparin assay" and "Berichrom Heparin UF Control 1 is an assayed, low level, quality control matenal for assessment of precision and analytical bias in the quantitative determination of unfractionated (UF) heparın with the Berichrom Heparın assay"
- Berichrom Heparin UF Control 2: "For use as a high level assayed control for the quantitative measurement of unfractionated (UF) heparm with the Berichrom Heparin assay" and "Berichrom Heparın UF Control 2 ıs an assayed, hıgh level, qualıty control material for assessment of precision and analytical bras in the quantitative determination of unfractionated (UF) heparin with the Berichrom Heparin assay"
Product codes (comma separated list FDA assigned to the subject device)
JPA, GGC, GIZ
Device Description
- Berichrom Heparin UF Calibrator: "Berichrom Heparin UF Calibrator is a lyophilized product containing unfractionated (UF) heparin from porcine intestine and buffered human plasma Each package contains 6 vials, each vial requires reconstitution with 1 0 mL distilled or deionized water"
- Berichrom Hepann UF Control 1: "Berichrom Heparin UF Control 1 is a lyophilized, low level, assayed control containing unfractionated (UF) heparin from porcine intestine and buffered human plasma Each package contains 6 vials, each vial requires reconstitution with 1 0 mL distilled or delonized water"
- Berichrom Heparin UF Control 2: "Benchrom Heparin UF Control 2 is a lyophilized, high level, assayed control containing unfractionated (UF) heparin from porcine intestine and buffered human plasma Each package contains 6 vials, each vial requires reconstitution with 1 0 mL distilled or deionized water"
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
§ 864.5425 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.
0
JAN 2 6 2009
Siemens Healthcare Diagnostics Inc 510(k) Notificalion Benchrom™ Hepann UF Calibrator
Benchrom™ Hepann UF Control 1 Benchrom™ Hepann UF Control 2
510(k) Summary for
Berichrom™ Heparin UF Calibrator Berichrom™ Heparin UF Control 1 Berichrom™ Heparin UF Control 2
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807 92
The assigned 510(k) number is K083175
A Manufacturer's Name, Address, Contact Information, and Date of Preparation
- 1 Manufacturer
Siemens Healthcare Diagnostics Products GmbH
Emil-von-Behring Str 76
35041 Marburg, Germany
-
2 Contact Information
Siemens Healthcare Diagnostics Inc -
500 GBC Dnve
Newark, Delaware 19702
Attention Janet Fose, Regulatory Affairs Specialist
Telephone 302-631-8826, Fax 302-631-6299
- m Preparation Date October 27, 2008
- B Name of Device(s)
Berichrom Heparın UF Calıbrator
Berichrom Heparin UF Control 1
Benchrom Heparin UF Control 2
1
Siemens Healthcare Diagnostics Inc 510(k) Notification Benchrom™ Hepann UF Calibrator Benchrom™ Heparin UF Control 1 Benchrom™ Hepann UF Control 2
C Regulatory Information
| 1 CFR Section(s) | 864 5425 - MULTIPURPOSE SYSTEM FOR IN VITRO COAGULATION STUDIES |
|---|---|
| 2 Classification(s) | Class II |
| 3 Classification Panel(s) | Hematology (81) |
JPA, GIZ, GGC
D Predicate Device(s)
4 Product Code(s)
Dade Behring Heparin Calibrator and Controls - K042941
E Device Description(s)
Berichrom Heparin UF Calibrator
Berichrom Heparin UF Calibrator is a lyophilized product containing unfractionated (UF) heparin from porcine intestine and buffered human plasma Each package contains 6 vials, each vial requires reconstitution with 1 0 mL distilled or deionized water
Berichrom Hepann UF Control 1
Berichrom Heparin UF Control 1 is a lyophilized, low level, assayed control containing unfractionated (UF) heparin from porcine intestine and buffered human plasma Each package contains 6 vials, each vial requires reconstitution with 1 0 mL distilled or delonized water
Berichrom Heparin UF Control 2
Benchrom Heparin UF Control 2 is a lyophilized, high level, assayed control containing unfractionated (UF) heparin from porcine intestine and buffered human plasma Each package contains 6 vials, each vial requires reconstitution with 1 0 mL distilled or deionized water
F Device Intended Uses
Berichrom Heparin UF Calibrator
For the callbration of the Berichrom Heparin assay for measurement of unfractionated (UF) heparın
Benchrom Heparın UF Control I
For use as a low level assayed control for the quantitative measurement of unfractionated (UF) heparin with the Benchrom Heparin assay
2
Siemens Healthcare Diagnostics Inc 510(k) Notification Benchrom™ Hepann UF Calibrator Benchrom™ Hepann UF Control 1 Benchrom™ Hepann UF Control 2
Benchrom Heparin UF Control 2
For use as a high level assayed control for the quantitative measurement of unfractionated (UF) heparm with the Berichrom Heparin assay
G Substantial Equivalence Information.
The Berichrom Heparin UF Calibrator, like the Dade Behring Heparin Calibrator, is intended for the callbration of the Benchrom Heparin assay for the measurement of unfractionated (UF) heparin Both the proposed device and the predicate device also share similarities in form, matrix and analyte measured
The Berichrom Heparin UF Control 1 and Berichrom Heparin UF Control 2 like, the Dade Behring Heparin Controls are assayed quality control materials and are intended for the measurement of UF heparin in the low and high concentration range, respectively Both the proposed devices and the predicate also share similarities in form, matrix and analyte measured
H Conclusion
Based on the information provided, the proposed devices are substantially equivalent to their respective predicate devices
3
Image /page/3/Picture/12 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the eagle. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES."
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics, Inc c/o Ms Janet M Fose Regulatory Affairs Specialist 500 GBC Drive, M/S 514 PO Box 6101 Newark, DE 19714
JAN 2 6 2009
Re K083175
Trade/Device Name Berichrom Heparin UF Calibrator Berichrom Heparın UF Control 1 Berichrom Heparin UF Control 2 Regulation Number 21 CFR 864 5425 Regulation Name Multıpurpose System for In Vitro Coagulation Studies Regulatory Class Class II Product Code JPA, GGC, GIZ Dated October 27, 2008 Received October 28, 2008
Dear Ms Fose
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 wth 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
4
Page 2
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
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,
m Chan
Maria M Chan, Ph D Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Berichrom Heparın UF Calıbrator
Indications for Use:
Berichrom Heparin UF Calibrator is an in vitro diagnostic product used for the calıbration of the Berichrom Heparın assay for measurement of unfractionated (UF) heparın
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
OR Over-The
(21 CFR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Dgwice Evaluation (ODE) Tice of In Vitro Diagnostic Der "Trains 1" " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "
6
Indications for Use
510(k) Number (if known):
Device Name: Berichrom Heparın UF Control 1
Indications for Use
Berichrom Heparin UF Control 1 is an assayed, low level, quality control matenal for assessment of precision and analytical bias in the quantitative determination of unfractionated (UF) heparın with the Berichrom Heparın assay
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bantin
Vitro Diagnosti
7
Indications for Use
510(k) Number (if known):
Device Name: Berichrom Heparın UF Control 2
Indications for Use:
Berichrom Heparın UF Control 2 ıs an assayed, hıgh level, qualıty control material for assessment of precision and analytical bras in the quantitative determination of unfractionated (UF) heparin with the Berichrom Heparin assay
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
'aluas'n ,-1) 6,
K083/75