(90 days)
Berichrom Heparin UF Calibrator is an in vitro diagnostic product used for the calibration of the Berichrom Heparin assay for measurement of unfractionated (UF) heparin.
Berichrom Heparin UF Control 1 is an assayed, low level, quality control material for assessment of precision and analytical bias in the quantitative determination of unfractionated (UF) heparin with the Berichrom Heparin assay.
Berichrom Heparin UF Control 2 is an assayed, high level, quality control material for assessment of precision and analytical bias in the quantitative determination of unfractionated (UF) heparin with the Berichrom Heparin assay.
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 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 deionized water.
Berichrom 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.
This 510(k) summary describes a submission for a set of calibrators and controls used with an assay to measure unfractionated heparin. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and performance data for the device itself. Therefore, many of the requested categories (such as sample size for test/training sets, expert ground truth, adjudication methods, and MRMC studies) are not applicable or provided in this type of submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or detailed performance data for the new devices (Berichrom Heparin UF Calibrator, Control 1, and Control 2). Instead, the submission is focused on demonstrating "substantial equivalence" to a predicate device (Dade Behring Heparin Calibrator and Controls - K042941). The "performance" described is the similarity in intended use, form, matrix, and analyte measured, which allows the new devices to be considered equivalent.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Equivalence | Proposed devices (Calibrator, Control 1, Control 2) have the same intended use as the predicate devices: calibration for unfractionated heparin measurement (Calibrator) and quality control for low and high ranges of unfractionated heparin (Controls). |
| Form Equivalence | Proposed devices are lyophilized products, similar to the predicate. |
| Matrix Equivalence | Proposed devices contain buffered human plasma, similar to the predicate. |
| Analyte Equivalence | Proposed devices contain unfractionated (UF) heparin from porcine intestine, similar to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for in vitro diagnostic (IVD) calibrators and controls seeking substantial equivalence, not a clinical study requiring test sets with patient data. No specific test set performance data is presented beyond the assertion of similarity to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for this type of IVD control and calibrator pertains to their ability to perform their intended function (calibrate or control an assay), which is assessed by manufacturer-defined specifications and comparison to a legally marketed predicate device, not through expert-established ground truth on patient samples.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for an in vitro diagnostic calibrator and control, 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 for an in vitro diagnostic calibrator and control, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established performance and characteristics of the legally marketed predicate device (Dade Behring Heparin Calibrator and Controls - K042941). The new devices are considered to meet their requirements by demonstrating substantial equivalence to this predicate.
8. The sample size for the training set
Not applicable. This submission doesn't describe a machine-learning device or a training set. The development of IVD reagents typically involves formulation and stability studies, rather than "training sets" in the AI sense.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device submission.
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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
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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
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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
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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
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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
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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" " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "
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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
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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
§ 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.