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

Indications for 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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k083159

B. Purpose for Submission:
Clearance of new device

C. Measurand:
Low molecular weight heparin

D. Type of Test:
Control/Calibrator

E. Applicant:
SIEMENS HEALTHCARE DIAGNOSTICS

F. Proprietary and Established Names:
Berichrom Heparin LMW Calibrator
Berichrom Heparin LMW Control 1
Berichrom Heparin LMW Control 2

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JPA | II | 21 CFR 864.5425 | 81 HEMATOLOGY |
| GIZ | II | 21 CFR 864.5425 | 81 HEMATOLOGY |
| GGC | II | 21 CFR 864.5425 | 81 HEMATOLOGY |

H. Intended Use:

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1. Intended use(s):

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.

2. Indication(s) for use:

3. Special conditions for use statement(s):

4. Special instrument requirements:

I. Device Description:

| **Berichrom Heparin LMW Calibrator** |
| --- |
| Berichrom 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** |

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Berichrom 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.

J. Substantial Equivalence Information:

| Predicate | Item | Similarities | Differences |
| --- | --- | --- | --- |
| Berichrom Heparin LMW Calibrator | | | |
| Calibration Plasma LMW Heparin - K030964 | Intended Use | For the calibration of low molecular weight heparin | For the calibration of the Berichrom Heparin assay, predicate can be used to calibrate chromogenic assays |
| | Form | Lyophilized | |
| | Matrix | Plasma | |
| | Traceability | WHO Standard | |
| | Levels | | One, predicate 3 levels |
| | | | |
| Berichrom Heparin LMW Control 1/2 | | | |
| Control Plasma LMW Heparin - K030965 | Intended Use | Assayed control for the measurement of low molecular control | |
| | Form | Lyophilized | |
| | Analyte | Low molecular weight | |
| | Matrix | Plasma | |
| | Levels | | 1 of each Control, sold separately, predicate 2 levels sold as a kit |

K. Standard/Guidance Document Referenced (if applicable):

| STANDARDS |
| --- |
| Title and Reference Number |
| |

Other Standards

| GUIDANCE | | |
| --- | --- | --- |
| Document Title | Office Division | Web Page |
| Guidance for | OIVD | http://www.fda.gov/cdrh/mdufma/guidance/1215.html |

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| Industry and FDA
Staff: Bundling
Multiple Devices or
Multiple
Indications in a
Single Submission | | |
| --- | --- | --- |
| Guidance for Industry
and FDA Staff -
Assayed and Unassayed
Quality Control
Material | OIVD | http://www.fda.gov/cdrh/oivd/guidance/2231.html |

L. Test Principle:

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

n/a

b. Linearity/assay reportable range:

n/a

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The assigned values for Berichrom Heparin LMW Calibrator, Berichrom Heparin LMW Control 1 and Berichrom Heparin LMW Control 2 are traceable to the 2nd World Health Organization (WHO) International Standard for low molecular weight heparin. Assigned values are obtained from multiple determinations, on multiple coagulation instruments and Berichrom Heparin lots. A typical assigned value for the calibrator is 1.40 IU/mL. Typical control values are 0.40 IU/mL for Control 1 and 0.90 IU/mL for Control 2.

Stability Testing

Shelf life (Closed)

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# Study Duration

24 month shelf life; studies performed for 1 month past labeled shelf life.

# Testing Frequency

Day 0; 6, 9, 12, 18, 19, 24 and 25 months

# Storage

+2 to +8°C

# Replicates

Calibrator: Three six-point calibration curves are generated from three vials of calibrator; a mean calibration curve is established from the three curves. At each time point, a vial is tested in duplicate.

Controls: At each time point, a vial is tested in duplicate.

# Acceptance Criteria

Calibrator & Controls: Results obtained must not deviate more than ±20% compared to Day 0 results.

The mean value at each time point is compared to the Day 0 is value. Results obtained must meet the acceptance criteria. Shelf-life (expiration) dating assignment at commercialization reflects the real-time data on file at Siemens Healthcare Diagnostics Inc.

# Reconstituted (Open)

## Study Duration

24 month shelf life; studies performed for 1 month past labeled shelf life

## Testing Frequency

Day 0; 6, 9, 12, 18, 19, 24 and 25 months

## Storage

+15 to +25°C; tested after reconstitution at various time points up to 25 hours

+2 to +8°C; tested after reconstitution at various time points up to 49 hours

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$\leq -18^{\circ}\mathrm{C}$; tested after reconstitution at various time points up to 5 weeks

## Replicates

Calibrator: Three six-point calibration curves are generated from three vials of calibrator; a mean calibration curve is established from the three curves. At each time point, a vial is tested in duplicate.

Controls: At each time point, a vial is tested in duplicate.

## Acceptance Criteria

Results obtained must not deviate more than $\pm 20\%$ compared to the freshly reconstituted vial results.

The mean value at each time point is compared to the value obtained from a freshly reconstituted vial. Results obtained must meet the acceptance criteria.

d. Detection limit:
n/a

e. Analytical specificity:
n/a

f. Assay cut-off:
n/a

2. Comparison studies:
a. Method comparison with predicate device:
n/a
b. Matrix comparison:
n/a

3. Clinical studies:
a. Clinical Sensitivity:

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n/a

b. Clinical specificity:

n/a

c. Other clinical supportive data (when a. and b. are not applicable):

n/a

4. Clinical cut-off:

n/a

5. Expected values/Reference range:

Values are determined using six reference curves derived on six coagulometer instruments with two different reagent lots. 1 run on each reference curve, 4 vials, and 2 replicates per vial tested for a total of 48 values. The assigned value is the mean of the 48 values.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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