DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL

K113373 · Siemens Healthcare Diagnostics, Inc. · JIT · Dec 30, 2011 · Clinical Chemistry

Device Facts

• Record ID: K113373
• Device Name: DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 30, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The LOCI 9 CAL is an in vitro diagnostic product for the calibration of the progesterone (PROG) method on the Dimension Vista® System.

Device Story

LOCI 9 Calibrator is a liquid, frozen, bovine serum albumin-based product containing progesterone, testosterone, buffers, and preservatives. It is packaged in ten vials across five levels (A-E). The device is used in a clinical laboratory setting on the Dimension Vista® System to calibrate the progesterone assay. Healthcare professionals use the system to measure progesterone levels in patient samples; the calibrator ensures the accuracy and traceability of these measurements by providing known concentration reference points. This calibration process is essential for the reliable quantification of progesterone, which aids clinicians in assessing patient endocrine status.

Clinical Evidence

No clinical data. Performance validation focused on traceability, value assignment, and stability testing.

Technological Characteristics

Liquid, frozen bovine serum albumin-based matrix. Contains progesterone, testosterone, buffers, and preservatives. Packaged in 1.5 mL vials. Designed for use with the Dimension Vista® System. No software or electronic components.

Indications for Use

Indicated for the calibration of the progesterone (PROG) method on the Dimension Vista® System. For prescription use only.

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

• Siemens Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide Calibrator (k080578)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness for the Dimension Vista® LOCI 9 Calibrator (KC647)

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.

A. 510(k) Number: K113373

- B. Date of Preparation: October 28, 2011
### C. Proprietary and Established Names:

Dimension Vista® LOCI 9 Calibrator, LOCI 9 CAL (KC647)

#### D. Applicant:

Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark, DE 19714-6101 Frances A. Dillon, Regulatory Affairs & Compliance Manager Office: [phone] Fax: [phone]

## E. Regulatory Information:

Dimension Vista® LOCI 9 Calibrator, LOCI 9 CAL (KC647)

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

### F. Predicate Device:

The predicate device used to demonstrate substantial equivalence is the Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide Calibrator, PBNP CAL (KC676A), cleared under K080578.

#### G. Device Description:

The LOCI 9 Calibrator is a liquid, frozen bovine serum albumin based product packaged as ten vials to a carton, with two vials at each of the 5 levels (A, B, C, D and E), 1.5 mL per vial. The LOCI 9 Calibrator includes progesterone, testosterone, buffers and preservatives.

Note: Although testosterone is present in this formulation, the LOCI 9 Calibrator will only be used with the Dimension Vista® Progesterone assay.

### H. Intended Use:

The LOCI 9 CAL is an in vitro diagnostic product for the calibration of the progesterone (PROG) method on the Dimension Vista® System.

## I. Substantial Equivalence Information:

The Dimension Vista® LOCI 9 Calibrator, LOCI 9 CAL (KC4647) was compared to the predicate device, Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide Calibrator, PBNP CAL (KC676A), cleared under K080578. The following tables provide a comparison of the important similarities and differences between the devices:

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## Similarities

| Feature | New Device<br>Dimension Vista® LOCI 9<br>Calibrator, LOCI 9 CAL (KC647) | Predicate<br>Dimension Vista® N-terminal Pro-<br>Brain Natriuretic Peptide<br>Calibrator, PBNP CAL (KC676A) |
|--------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use. | For in vitro diagnostic use. |
| Matrix | Bovine serum albumin based | Bovine serum albumin based |
| Form | Liquid, frozen | Liquid, frozen |
| # Levels | Ten vials, two vials per level, 5 levels<br>(A, B, C, D and E) | Ten vials, two vials per level, 5<br>levels (A, B, C, D and E) |

## Differences

| Feature | New Device<br>Dimension Vista® LOCI 9<br>Calibrator, LOCI 9 CAL (KC647) | Predicate<br>Dimension Vista® N-terminal Pro-<br>Brain Natriuretic Peptide<br>Calibrator, PBNP CAL (KC676A) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LOCI 9 CAL is an <i>in vitro</i><br>diagnostic product for the calibration<br>of the progesterone (PROG) method<br>on the Dimension Vista® System. | The PBNP CAL is an <i>in vitro</i><br>diagnostic product for the calibration<br>of the N-terminal Pro-Brain<br>Natriuretic Peptide (PBNP) method<br>on the Dimension Vista® System. |
| Analyte | Progesterone | Synthetic PBNP |
| Volume | 1.5 mL per vial | 1.0 mL per vial |
| Typical<br>Concentration<br>Levels | Five Levels, (0, 1.0, 8.0, 20.0 and<br>44.0 ng/mL) | Five levels, (0, 250, 1500, 12,000<br>and 36,750 pg/mL) |

## J. Performance:

The traceability, value assignment and stability of the Dimension Vista® LOCI 9 Calibrator have been validated following procedures of Siemens Healthcare Diagnostics, Inc.

## K. Conclusion:

The Dimension Vista® LOCI 9 Calibrator (KC4647) is substantially equivalent in design and intended use to the previously cleared Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide Calibrator (KC676A).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics, Inc. c/o Frances A. Dillon P.O. Box 6101 Mailstop 514 Newark, DE 19714-6101 USA

DEC 3 0 2011

Re: k113373

Trade Name: Dimension Vista® LOCI 9 Calibrator Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIT Dated: November 15, 2011 Received: November 16, 2011

Dear Ms. Dillon:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...

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/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

N

Couriney H. Lias, Ph.D. Director Division of Chemistry and Toxicology 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:

Dimension Vista® LOCI 9 Calibrator

## Indications for Use:

The LOCI 9 CAL is an in vitro diagnostic product for the calibration of the progesterone (PROG) method on the Dimension Vista® System.

X and/or Over-the-counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)

Heonath

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

510(k) K113373

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