LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621

K081683 · Siemens Healthcare Diagnostics · JIT · Jul 7, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081683
• Device Name: LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jul 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The LOCI® TNI Calibrator is an in vitro diagnostic product for the calibration of the Cardiac Troponin I (TNI) method on the Dimension® EXL™ integrated chemistry system with LOCI® module.

Device Story

LOCI® Cardiac Troponin I Calibrator is a liquid, frozen, human serum-based product containing native human troponin complex. Used in clinical laboratory settings to calibrate the Cardiac Troponin I method on the Dimension® EXL™ integrated chemistry system. Calibrator levels are assigned values ranging from 0 to 43 ng/mL. Healthcare professionals use the device to ensure the accuracy and traceability of the Troponin I assay, which aids in the clinical assessment of cardiac conditions.

Clinical Evidence

No clinical data. Bench testing only. Stability demonstrated via real-time data from 3 lots; shelf-life established at 12 months at -20°C, with 24-hour open-vial stability at 2-8°C. Value assignment validated against master pools and anchor pools using the Siemens Stratus CS analyzer.

Technological Characteristics

Liquid, frozen human serum-based calibrator. Contains native human troponin complex. Traceable to an internal master pool. Designed for use with the Dimension® EXL™ integrated chemistry system with LOCI® module. No specific materials or software algorithm classes are detailed beyond the chemical composition for calibration.

Indications for Use

Indicated for the calibration of the Cardiac Troponin I (TNI) assay on the Dimension® EXL™ integrated chemistry system with LOCI® module. No specific patient population, age, or gender restrictions are defined for this in vitro diagnostic calibrator.

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® Cardiac Troponin I Calibrator (K053577)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness LOCI® Cardiac Troponin I Calibrator

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigncd 510(k) number is:

081683

#### 1. Submitter's Contact Information and Date of Preparation

Mrs. Yuk-Ting Lewis Submitter's Contact Information: Siemens Healthcare Diagnostics Inc. P.O. Box 6101 Newark, DE 19714 Tel: [phone]

Date of Preparation:

June 12, 2008

#### Proprietary Device Name / FDA Classification Name 2.

LOCI® Cardiac Troponin I Calibrator / 21 CFR 862.1150

#### 3. Identification of the Predicate Device

Dimension Vista® Cardiac Troponin I Calibrator, K053577

#### Device Description 4.

The LOCI® Cardiac Troponin I Calibrator is a liquid, frozen, human serum based product containing native human troponin complex with other components designed to stabilize the product. The calibrator levels and their nominal values are:

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#### క. Device Intended Use

The LOCI® TNI CAL is an in vitro diagnostic product for the calibration of the Cardiac Troponin I (TNI) method on the Dimension® EXL™ integrated chemistry system with LOCI® module.

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#### 6. Summary of the devices technological characteristics

A comparison of the LOCI® Cardiac Troponin I Calibrator vs. the predicate device is provided.

| Feature | Predicate Device:<br>Dimension Vista® Cardiac<br>Troponin I Calibrator | New Device:<br>LOCI® Cardiac Troponin I<br>Calibrator |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CTNI CAL is an in vitro<br>diagnostic product for the<br>calibration of Cardiac Troponin<br>I (CTNI) on the Dimension<br>Vista system. | The LOCI® TNI CAL is an in<br>vitro diagnostic product for the<br>calibration of the Cardiac<br>Troponin I (TNI) method on the<br>Dimension® EXL™ integrated<br>chemistry system with LOCI®<br>module. |
| Analyte | Human troponin complex | |
| Matrix | Human serum | |
| Form | The calibrators are in a liquid, frozen form. | |
| Calibrator levels | The CTNI Calibrator kit<br>contains twelve (12) vials; two<br>at each level. The nominal<br>values are 0, 0.4, 4, 8, 20, and<br>41 ng/mL. | The LOCI® TNI Calibrator kit<br>contains ten (10) vials; two vials<br>at each level. The nominal<br>values are 0.00, 0.60, 6.00,<br>20.00, and 43.00 ng/mL. |
| Stability | The stability of the calibrators is established through real-time data<br>on 3 lots of product. Testing is conducted at multiple time points<br>and must pass pre-defined acceptance criteria. | |
| Traceability | The calibrator is traceable to an internal master pool containing<br>human cardiac troponin complex. | |

### 7. Conclusion

Based on a review of the devices technological features, the LOCI® Cardiac Troponin I Calibrator is substantially equivalent to the legally marketed device, the Dimension Vista® Cardiac Troponin I Calibrator.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Healthcare Diagnostics, Inc. c/o Yuk-Ting Lewis RA & Compliance Manager P.O. Box 6101, M/S 514 Newark, DE 19714

JUL - 7 2008

Re: k081683 Trade/Device Name: LOCI® Cardiac Troponin I Calibrator Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: June 13, 2008 Received: June 17, 2008

Dear Ms. Lewis:

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 note 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 toll-free number [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.

Yean 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

K081683 510(k) Number (if known):

Device Name: LOCI® Cardiac Troponin I Calibrator

Indications For Use:

The LOCI® TNI CAL is an in vitro diagnostic product for the calibration of the Cardiac Troponin I (TNI) 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) K081683

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