(91 days)
Not Found
No
The device description and intended use clearly define the product as calibrators and controls for a heparin assay, which are chemical reagents and not software or hardware incorporating AI/ML. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is described as an in vitro diagnostic product used for calibration and quality control in the measurement of low molecular weight (LMW) heparin, not for direct therapeutic use in patients.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Berichrom Heparin LMW Calibrator is an in vitro diagnostic product." It also describes the controls as being used for "assessment of precision and analytical bias in the quantitative determination of low molecular weight (LMW) heparin," which falls under in vitro diagnostics.
No
The device description clearly states that the products are lyophilized materials containing biological components, requiring reconstitution with water. This indicates a physical, in vitro diagnostic reagent, 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 document explicitly states that the products are "in vitro diagnostic products" used for the calibration and quality control of an assay that measures low molecular weight heparin. This directly aligns with the definition of an IVD, which are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the composition of the products, which are intended to be used in a laboratory setting with the Berichrom Heparin assay.
- Predicate Devices: The mention of predicate devices (K030964 and K030965) which are also described as "Calibration Plasma LMW Heparin" and "Control Plasma LMW Heparin" further supports the classification of these products as IVDs. These predicate devices are likely also IVDs used for similar purposes.
The absence of information about image processing, AI/ML, imaging modality, anatomical site, patient age range, intended user/care setting, training/test sets, performance studies, and key metrics is expected for a calibrator and control material, as these are not typically features or requirements for such IVD components.
N/A
Intended Use / Indications for Use
Berichrom Heparin LMW Calibrator: "Berichrom Heparin LMW Calibrator is an in vitro diagnostic product used for the calibration of the Benchrom Heparin assay for measurement of low molecular weight (LMW) heparin."
Berichrom Heparin LMW Control 1: "Benchrom Heparin LMW Control 1 is an assayed, low level, quality control material for assessment of precision and analytical bias in the quantitative determination of low molecular weight (LMW) heparin with the Berichrom Heparin assay."
Berichrom Heparin LMW Control 2: "Benchrom Heparin LMW Control 2 is an assayed, high level, quality control material for assessment of precision and analytical bias in the quantitative determination of low molecular weight (LMW) heparin with the Berichrom Heparin assay."
Product codes (comma separated list FDA assigned to the subject device)
JPA, GIZ, GGC
Device Description
Berichrom Heparin LMW Calibrator: "Berichtom Heparin LMW Calibrator is a lyophilized product containing low molecular weight (LMW) 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 LMW Control 1: "Berichrom Heparin LMW Control 1 is a lyophilized, low level, assayed control containing low molecular weight (LMW) 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 LMW Control 2: "Benchrom Heparin LMW Control 2 is a lyophilized, high level, assayed control containing low molecular weight (LMW) 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.
Calibration Plasma LMW Heparin - K030964, Control Plasma LMW Heparin - K030965
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) Notification Benchrom™ Hepann LMW Calibrator
Benchrom™ Hepann LMW Control 1 Benchrom™ Hepann LMW Control 2
510(k) Summary for
Berichrom™ Heparın LMW Calıbrator Berichrom™ Heparin LMW Control 1 Berichrom™ Heparın LMW 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 K083159
A Manufacturer's Name, Address, Contact Information, and Date of Preparation
- س Manufacturer
Siemens Healthcare Diagnostics Products GmbH
Emil-von-Behring Str 76
35041 Marburg, Germany
- 2 Contact Information
Siemens Healthcare Diagnostics Inc
500 GBC Drive
Newark, Delaware 19702
Attention Janet Fose, Regulatory Affairs Specialist
Telephone 302-631-8826, Fax 302-631-6299
- m Preparation Date October 24, 2008
- B Name of Device(s)
Berichrom Heparin LMW Calibrator
Berichrom Heparın LMW Control 1
Berichrom Heparin LMW Control 2
1
Siemens Healthcare Diagnostics Inc 510(k) Notification Benchrom™ Hepann LMW Calibrator Benchrom™ Hepann LMW Control 1 Benchrom™ Hepann LMW Control 2
C Regulatory Information.
| I CFR Section(s) | 864 5425 - MULTIPURPOSE SYSTEM FOR IN VITRO
COAGULATION STUDIES |
|---------------------------|--------------------------------------------------------------------|
| 2 Classification(s) | Class II |
| 3 Classification Panel(s) | Hematology (81) |
| 4 Product Code(s) | JPA, GIZ, GGC |
D Predicate Device(s)
Calibration Plasma LMW Heparın - K030964
Control Plasma LMW Heparin - K030965
E Device Description(s)
Berichrom Hepann LMW Calibrator
Berichtom Heparin LMW Calibrator is a Ivophilized product containing low molecular weight (LMW) 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 LMW Control 1
Berichrom Heparin LMW Control 1 is a lyophilized, low level, assayed control containing low molecular weight (LMW) heparin from porcine intestine and buffered human plasma Each package contains 6 vials, each vial requires reconstitution with 1 0 mL distilled or deronized water
Berichrom Heparın LMW Control 2
Benchrom Heparin LMW Control 2 is a lyophilized, high level, assayed control containing low molecular weight (LMW) heparin from porcine intestine and buffered human plasma Each package contains 6 vials, each vial requires reconstitution with 1 0 mL distilled or deronized water
F Device Intended Uses
Berichrom Heparin LMW Calibrator
For the calibration of the Berichrom Heparin assay for measurement of low molecular werght (LMW) heparın
Berichrom Heparin LMW Control 1
For use as a low level assayed control for the quantitative measurement of low molecular weight (LMW) heparin with the Berichrom Heparin assay
2
Siemens Healthcare Diagnostics Inc 510{k) Notification Benchrom™ Hepann LMW Calibrator Benchrom™ Hepann LMW Control 1 Benchrom™ Hepann LMW Control 2
Berichrom Heparin LMW Control 2
For use as a high level assayed control for the quantitative measurement of low molecular weight (LMW) heparin with the Berichrom Heparin assay
G Substantial Equivalence Information
The Berichrom Heparin LMW Calibrator, like the Calibration Plasma LMW Heparin, is intended for the calibration of low molecular weight (LMW) heparin Both the proposed device and the predicate also share similarities in form, matrix and traceability
The Berichrom Heparin LMW Control 1 and Benchrom Heparin LMW Control 2 are substantially equivalent to Control Plasma LMW Heparin The Berichrom Heparin LMW Control 1 and Benchrom Heparin LMW Control 2 like, the Control Plasma LMW Heparin are assayed quality control materials and are intended for the measurement of LMW heparin in the low and high concentration range, respectively Both the proposed devices and the predicate also share similarities in form, matrix and traceability
H Conclusion
Based on the information provided, the proposed devices, the proposed devices are substantially equivalent to their respective predicate devices
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Garther 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 K083159
Trade/Device Name Berichrom Heparin LMW Calibrator Berichrom Heparın LMW Control 1 Berichrom Heparin LMW Control 2 Regulation Number 21 CFR 864 5425 Regulation Name Multipurpose System for In Vitro Coagulation Studies Regulatory Class Class II Product Code JPA, GGC, GIZ Dated October 24, 2008 Received October 27, 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 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
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 Brometric'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,
In 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 LMW Calıbrator
Indications for Use:
Berichrom Heparin LMW Calıbrator is an in vitro diagnostic product used for the calibration of the Benchrom Heparin assay for measurement of low molecular weıght (LMW) heparın
| Prescription Use (Part 21 CFR 801 Subpart D) | X | 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)
Office of In Vitro Diagnostic Device Evaluation and Safety
| K083159 |
|---|
| --------- |
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Indications for Use
510(k) Number (if known): Ko & 31-9
Device Name. Benchrom Heparin LMW Control 1
Indications for Use
Benchrom Heparın LMW Control 1 is an assayed, low level, quality control material for assessment of precision and analytical bras in the quantitative determination of low molecular weight (LMW) 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 Deyne Evaluation (ODE)
Josephine Bautista
fice of in Viro " 17 more 19 De י ג' דים ריטי מטיים aluz
K 083159
7
Indications for Use
510(k) Number (if known):
Device Name: Benchrom Heparın LMW Control 2
Indications for Use:
Benchrom Heparin LMW Control 2 is an assayed, high level, quality control matenal for assessment of precision and analytical bras in the quantitative determination of low molecular weight (LMW) heparın with the Berichrom Heparın 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)
Josephine Bautista