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

Intended 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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# OCT 1 0 2008

#### 510(k) Summary of Safety and Effectiveness for the Dimension® EXL™ LOCI® NTP Calibrator (RC623)

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.

Ko82680

### B. Date of Preparation: August 26, 2008

#### C. Proprietary and Established Names:

Dimension® EXL™ LOCI N-terminal Pro-Brain Natriuretic Peptide Calibrator (LOCI NTP Calibrator - RC623)

#### D. Applicant:

A. 510(k) Number: _

Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Senior Manager, Regulatory Affairs Office: [phone] Fax: [phone]

#### E. Regulatory Information:

- 1. Regulation section: 21 CFR § 862.1150 Calibrator, Secondary
- 2. Classification: Class II
- 3. Product Code: JIT, Calibrator, Secondary
- 4. Panel: Clinical Chemistry

#### F. Predicate Device:

The LOCI NTP Calibrator (RC623) is substantially equivalent to the Dimension Vista® PBNP Calibrator (KC676A) cleared under K080578.

#### G. Device Description:

The LOCI NTP CAL is a frozen liquid product containing synthetic human N-terminal pro-brain natriuretic peptide in bovine albumin matrix with stabilizers and preservative. The kit consists of ten vials, two vials per level (A, B, C, D, and E), 1.0 mL per vial. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.

#### H. Intended 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 LOCl® Module.

#### I. Substantial Equivalence Information:

The LOCI NTP Calibrator (RC623) and the predicate Dimension Vista® PBNP Calibrator (KC676A) were compared. A comparison of the important similarities and differences between the devices and the predicates is provided in the following table:

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| Feature | LOCI NTP CAL | Dimension Vista® PBNP Flex®<br>Calibrator (KC676A)<br>(K080578) |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | The LOCI NTP CAL is an in vitro<br>diagnostic product for the calibration<br>of the N-terminal pro-brain natriuretic<br>peptide (NTP Cat. No. RF623)<br>methods on the Dimension® EXL™<br>integrated chemistry system with<br>LOCI® Module. | The PBNP CAL is an in vitro<br>diagnostic product for the calibration<br>of the N-Terminal Pro-Brain<br>Natriuretic Peptide (PBNP) method for<br>the Dimension Vista® System. |
| Analyte | Synthetic PBNP | Synthetic PBNP |
| Matrix | Bovine Albumin | Bovine Albumin |
| Form | Liquid, frozen | Liquid, frozen |
| Volume | Ten vials, two vials per level (A, B, C,<br>D, and E), 1.0 mL per vial. | Ten vials, two vials per level (A, B, C,<br>D, and E), 1.0 mL per vial. |
| Levels | Five Levels, (0, 250, 1500, 12,000,<br>36,750 pg/mL) | Five Levels, (0, 250, 1500, 12,000,<br>36,750 pg/mL) |

## J. Conclusion:

The Dimension® EXL™ LOCI N-terminal Pro-Brain Natriuretic Peptide Calibrator (RC623) is substantially equivalent to the predicate Dimension Vista® PBNP Calibrator (KC676A) cleared under K0080578. Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle-like emblem with three stylized lines forming its body and wings. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A.", arranged in a circular fashion around the emblem.

Public Health Service

OCT 1 0 2008

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Healthcare Diagnostics, Inc. c/o Mr. Victor Carrio Senior Manager of Regulatory Affairs P.O. Box 6101, Mail Stop 514 Newark, DE 19714-6101

Re: k082680

> Trade Name: LOCI N-Terminal Pro-Brain Natriuretic Peptide Calibrator (RC623) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIT Dated: September 12, 2008 Received: September 15, 2008

Dear Mr. Carrio:

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).

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Page 2 -

This letter will allow you to begin 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please not the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollit the [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Jéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indication for Use

K 7 8 2 6 8 3 510(k) Number (if known):

Device Name:

LOCI N-Terminal Pro-Brain Natriuretic Peptide Calibrator (RC623)

Indication 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.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K082680

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