LOCI 8 CALIBRATOR, MODEL KC 646

K101460 · Siemens Healthcare Diagnostics · JIX · Jul 9, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101460
• Device Name: LOCI 8 CALIBRATOR, MODEL KC 646
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jul 9, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The LOCI 8 CAL is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL) and estradiol (E2) methods on the Dimension Vista® Systems.

Device Story

LOCI 8 CAL is a multi-analyte, liquid, frozen, bovine serum albumin-based calibrator. It contains FSH, LH, prolactin, and estradiol. Used on the Dimension Vista® System to calibrate quantitative assays for these hormones. The calibrator is intended for professional use in clinical laboratory settings. It provides reference values for the system to ensure accurate patient sample measurement. The device benefits patients by enabling precise hormone level quantification, which supports clinical decision-making regarding reproductive health and endocrine function.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (shelf life, open vial, punctured vial, stress testing) confirmed performance over 12 months at -20°C and 7 days at 2-8°C. Traceability established via WHO standards and ID/GC/MS reference methods.

Technological Characteristics

Multi-analyte, liquid, frozen bovine serum albumin-based calibrator. Contains human FSH, human LH, recombinant human PRL, and estradiol. Five-level concentration format. Stored at -25 to -15°C. Traceable to WHO International Standards and ID/GC/MS reference methods. Designed for use with Dimension Vista® 1000T, 500, 1500, and 3000T systems.

Indications for Use

Indicated for the calibration of FSH, LH, PRL, and E2 assays on the Dimension Vista® System for in vitro diagnostic use.

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 Calibrator B (k962041)
• Roche Estradiol II CalSet II (k992981)

Submission Summary (Full Text)

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K101460

### 510(k) Summary for LOCI 8 Calibrator

This summary of 510(k) safety and effectiveness information is being submitted in accordance This summaly of 510(K) Salety and Shouw 21.0.1.
with the requirements of SMDA 1990 and 21 CFR 807.92.

Siemens Healthcare Diagnostics, Inc.

The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________

| 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation: |
|--------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------|

| Manufacturer: | |
|---------------|--|
|---------------|--|

500 GBC Drive

JUL - 9 2010

Newark, DE 19714

Siemens Healthcare Diagnostics, Inc. Contact Information:

500 GBC Drive

Newark, DE 19714

Attn: A. Kathleen Ennis

Tel: [phone]

Fax: [phone]

April 26, 2010 Preparation date:

LOCI 8 Calibrator 2. Device Name:

| Classification: | Class II |
|-----------------|-------------------------|
| Product Code: | JIX; |
| Panel: | Clinical Chemistry (75) |

ldentification of the Legally Marketed Device: 3. Siemens Calibrator B, k962041 (FSH, LH, Prolactin) Sicments Calibrati CalSet II , k992981 (Estradiol)

Device Descriptions: 4.

LOCI 8 CAL is a multi-analyte, liquid, frozen bovine serum albumin based product containing LOCT 8 CAL is a multi-analyte, liquid, frozen bovino oormone, recombinant human prolactin, estradiol, buffers and preservatives.

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#### Device Intended Uses: 5.

## Dimension LOCI 8 Calibrator

The LOCI 8 is an in vitro diagnostic product for the calibration of the Prolactin (PRL), Luteinizing The LOCI 8 is an in vitro diagnostic product for the Calibration of the Production (PRO) (CONTRO Commone Vista® system.

Medical device to which equivalence is claimed and comparison information:
Californial California includent to Siemors Calibrator B and Roche Estradiol Ca 6. The LOCI 8 CAL is substantialy equivalent to Sements Culibricon of and for the local for the
ll. Like the predicates, LOCI 8 is an in vitro diagnostic product intended to be II. Like the predicates, LOCI o'ls an in MIFO diagnound provinsity of the president of

## 7. Comparative Features Table

| Feature | Predicate Device<br>Siemens Calibrator B<br>(k962041) | New Device<br>Dimension Vista® LOCI 8 CAL |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities<br>Intended Use: | Calibrator B is for in vitro<br>diagnostic use in the<br>calibration of the following<br>assays FSH, LH and<br>Prolactin. | LOCI 8 CAL is an in vitro diagnostic<br>product for calibration of the follicle<br>stimulating hormone (FSH),<br>luteinizing hormone (LH) and prolactin<br>(PRL). |
| Constituents: | FSH, LH, Prolactin. | FSH, LH, prolactin, |
| Traceability of<br>constituents: | FSH<br>LH<br>Prolactin | FSH - WHO 1st IS for FSH 92/510<br>LH - WHO 2nd IS for LH 80/552<br>Prolactin - WHO 3rd IS for PRL 84/500 |
| Differences<br>Intended Use | Calibrator B is for use on the<br>ADVIA Centaur® or ACS:180 | LOCI 8 CAL is for use on the<br>Dimension Vista® System. |
| | systems<br>Calibrator B is also used for<br>the calibration of digoxin,<br>Total IGE, Total hCG and | LOCI 8 Calibrator is also used for<br>estradiol (E2). |
| Form | TSH<br>Lyophilized equine serum | frozen liquid, bovine serum albumin |
| Traceability of<br>Constituents | | Estradiol - Isotope Dilution gas<br>chromatography mass spectroscopy<br>reference measurement procedure |
| Levels:<br>Stability and | 2<br>Calibrator B is stored at 2 - 8 ° | 5<br>LOCI 8 CAL is stored at - 25 to -15 ° |

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° C. storage

C.

Calibrator B is stable, Calibratituted for 28 days @ 2 - 8 ° C.

LOCI 8 CAL is stable, thawed and LOCT o CAL is stable, the stable, to a ° C.
unopened for 8 days @ 2 – 8 ° C.

| Feature | Predicate Device<br>Roche - Estradiol II CalSet II<br>(k992681) | New Device<br>Dimension Vista® LOCI 8 CAL |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities<br>Intended Use: | Elecsys Estradiol II CalSet II<br>is an in vitro diagnostic<br>product used for calibrating a<br>quantitative estradiol assay. | LOCI 8 CAL is an in vitro diagnostic<br>product for calibration of a<br>quantitative estradiol assay. |
| Constituents: | Estradiol | Estradiol |
| Traceability of<br>constituents: | The Elecsys Estradiol II<br>assay has been standardized<br>using ID-GC/MS (isotope<br>dilution-gas chromatography). | The E2 assay on the Dimension<br>Vista® has been standardized using<br>ID-GC/MS (isotope dilution-gas<br>chromatography). |
| Differences<br>Intended Use | The Elecsys Estradiol II<br>CalSet II is for use on the<br>Elecsys and cobas e<br>immunoassay analyzers.<br>The Elecsys Estradiol II<br>CalSet II is for use only in the<br>calibration of Estradiol II. | LOCI 8 CAL is for use on the<br>Dimension Vista® System.<br>LOCI 8 Calibrator is also used for the<br>calibration of follicle stimulating<br>hormone (FSH), luteinizing hormone<br>(LH) and prolactin (PRL). |
| Form | Lyophilized human serum | frozen liquid, bovine serum albumin |
| Levels:<br>Stability and<br>storage | 2<br>Elecsys Estradiol II CalSet II<br>is stored at 2-8 °C. | 5<br>LOCI 8 CAL is stored at - 25 to -15 °C. |
| | Elecsys Estradiol II CalSet II<br>is stable, reconstituted three<br>months when stored at - 20 °C. | LOCI 8 CAL is stable, thawed and<br>unopened for 8 days @ 2 – 8 °C |

#### Conclusion 8.

LOCI 8 CAL, is substantially equivalent in intended use to the legally marketed devices, Siemens
, Sales (1200011) and Roobe — Estradiol II CalSet II (k992981) based on the LOCI 8 CAL, is substantially equivalent in intended use to the legally managed with in the information
Calibrator B (k962041) and Roche – Estradiol II CalSet II (k992981) bas described above.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Public Health Service

Siemens Healthcare Diagnostics, Inc. c/o Ms. Anna Marie Ennis Senior Regulatory Affairs & Compliance Specialist 500 GBC Drive, PO Box 6101 Newark, Delaware 19714-61015

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Re: k101460

> Trade Name: Loci 8 Calibrator, Model KC 646 Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIX Dated: May 25, 2010 Received: May 26, 2010

JUL 0 9 2010

Dear Ms. Ennis:

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/MedicalDevices/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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

CFC

Courtney C. Harper, Ph.D. Directør 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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# Indications for Use Form

510(k) Number (if known): _K \ O \ 님 O

LOCI 8 CAL Device Name:

LOCI 8 CAL is an in vitro diagnostic product for the calibration Indications for Use: of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL) and estradiol (E2)methods on the Dimension Vista® Systems .

Over-The-Counter Use XX Prescription Use AND/OR (21 CFR 801 Subpart C) Freschplion 2001 Subpart D)

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

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

Carol Benaim

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

510(k) K101460

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