LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623

K082680 · Siemens Healthcare Diagnostics · JIT · Oct 10, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082680
• Device Name: LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Oct 10, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The LOCI NTP CAL is an in vitro diagnostic product for the calibration of the Nterminal pro-brain natriuretic peptide (NTP Cat. No. RF623) method on the Dimension® EXL™ integrated chemistry system with LOCI® Module.

Device Story

LOCI NTP Calibrator is a frozen liquid product containing synthetic human N-terminal pro-brain natriuretic peptide in a bovine albumin matrix with stabilizers and preservatives. It is used in clinical laboratory settings to calibrate the NTP assay method on the Dimension EXL integrated chemistry system with LOCI Module. The calibrator kit consists of five levels (0, 250, 1500, 12,000, and 36,750 pg/mL) provided in ten vials. By establishing a calibration curve on the instrument, the device enables accurate quantification of NTP levels in patient samples, which assists healthcare providers in assessing cardiac health and clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Stability and shelf-life were validated by comparing stored product against control material at -70 °C. Traceability was established via the Dimension EXL NTP method to the Elecsys PBNP assay.

Technological Characteristics

Frozen liquid calibrator; synthetic human N-terminal pro-brain natriuretic peptide in bovine albumin matrix; five-level concentration range (0-36,750 pg/mL); designed for use with Dimension EXL integrated chemistry system with LOCI Module.

Indications for Use

Indicated for the calibration of N-terminal pro-brain natriuretic peptide (NTP) assays on the Dimension EXL integrated chemistry system. No specific patient population, age, or gender contraindications are defined for this calibrator product.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Dimension Vista® PBNP Calibrator (k080578)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k082680

B. Purpose for Submission:
New device

C. Measurand:
Calibrator material for N-terminal-pro-brain natriuretic peptide

D. Type of Test:
Calibrator material

E. Applicant:
Siemens Healthcare Diagnostics Inc.

F. Proprietary and Established Names:
LOCI NTP CAL

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1150 Calibrator, secondary
2. Classification:
Class II
3. Product code:
JIT
4. Panel:
75 Chemistry

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H. Intended Use:

1. Intended use(s):

See Indications for use below.

2. Indication(s) for use:

The LOCI NTP CAL is an in vitro diagnostic product for the calibration of the N-terminal pro-brain natriuretic peptide methods on the Dimension® EXL integrated chemistry system with LOCI® Module.

3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

Dimension ® EXL integrated chemistry system with LOCI® Module

I. Device Description:

The LOCI NTP CAL is a frozen liquid product containing synthetic human N-terminal peptide in bovine albumin matrix with stabilizers and preservative. The kit consists of ten vials, two vials per level (1, 2, 3, 4 and 5), 1.0 mL per vial.

The calibrator contains human source material. Each donor unit used in the preparation of this product was tested by FDA-approved methods for the presence of antibodies to Human immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2), and found to be negative (not repeatedly reactive).

J. Substantial Equivalence Information:

1. Predicate device name(s):

Dimension Vista® PBNP Calibrator

2. Predicate K number(s):

k080578

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analyte | Synthetic PBNP | Synthetic PBNP |
| Matrix | Bovine albumin | Bovine albumin |
| Form | Liquid, frozen | Liquid, frozen |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Instrument | Dimension ® EXL integrated chemistry system with LOCI® Module | Dimension Vista® |

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

None were referenced

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

Not applicable

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

The LOCI NTP CAL is a liquid product packaged as ten vials, two vials at each of five levels, to be stored at $-20^{\circ}\mathrm{C}$. The artificial matrix is BSA based spiked with synthetic NT-proBNP peptide. The master pool is a multi-level

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liquid BSA-based artificial matrix spiked with synthetic NT-proBNP peptide stored at -70 °C. Values are assigned to each lot of calibrator from the master pool using the Dimension® EXL NTP method. Values are assigned to the master pool from the patient sample anchor pool which has been assigned on the Elecsys PBNP assay to which the Dimension® EXL NTP method is traceable.

The LOCI NTP CAL is stored at -20 to -10 °C and is stable until the expiration date. Thawed unopened product is stable for 30 days at 2-8 °C. Once the vial is opened, assigned values are stable for 30 days when recapped immediately after use and stored at 2-8 °C. The shelf life and open stability of the calibrator have been demonstrated using real time data. Shelf life is determined by comparing results of the product stored at -20 °C with the control material stored at -70 °C. Open vial stability is determined by comparing results of vials thawed, opened and recapped stored at 4 °C up to 31 days with the control material and test material stored at -70 °C and -20 °C.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable

b. Matrix comparison:

Not applicable

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

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Not applicable

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

Not applicable

4. Clinical cut-off:

Not applicable

5. Expected values/Reference range:

Values for the calibrator materials are provided on the labels.

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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