BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2

K083159 · Siemens Healthcare Diagnostics · JPA · Jan 26, 2009 · Hematology

Device Facts

• Record ID: K083159
• Device Name: BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JPA · Hematology
• Decision Date: Jan 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

Berichrom Heparin LMW Calibrator is an in vitro diagnostic product used for the calibration of the Berichrom Heparin assay for measurement of low molecular weight (LMW) heparin. Berichrom 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 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.

Device Story

Lyophilized calibrator and quality control materials containing porcine-derived low molecular weight (LMW) heparin and buffered human plasma; intended for use with Berichrom Heparin assay on coagulation instruments. Calibrator establishes calibration curves; controls assess precision and analytical bias. Reconstituted with distilled or deionized water. Used in clinical laboratory settings by trained personnel. Values are traceable to 2nd WHO International Standard for LMW heparin. Provides standardized reference points for quantitative heparin measurement, ensuring assay accuracy and reliability for clinical decision-making regarding anticoagulation therapy.

Clinical Evidence

No clinical data. Performance supported by analytical bench testing, including shelf-life stability studies (closed and open-vial) and value assignment verification. Acceptance criteria required results to remain within ±20% of baseline/freshly reconstituted values.

Technological Characteristics

Lyophilized, buffered human plasma containing porcine-derived LMW heparin. Reconstitution required with 1.0 mL distilled or deionized water. Class II, product codes JPA, GIZ, GGC. In vitro diagnostic reagents.

Indications for Use

Indicated for use as a calibrator and quality control material for the quantitative measurement of low molecular weight heparin in human plasma samples using the Berichrom Heparin assay.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Calibration Plasma LMW Heparin (K030964)
• Control Plasma LMW Heparin (K030965)

Submission Summary (Full Text)

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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 [phone], Fax [phone]

- 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

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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<br>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

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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

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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

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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 [phone] 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 [phone] For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone] 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 [phone] or [phone] 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

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# 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

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# 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

K083159