ELECSYS LH CALSET II

K031299 · Roche Diagnostics Corp. · JIT · May 12, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031299
• Device Name: ELECSYS LH CALSET II
• Applicant: Roche Diagnostics Corp.
• Product Code: JIT · Clinical Chemistry
• Decision Date: May 12, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Elecsys LH CalSet II is used for calibrating the quantitative LH assay on the Elecsys immunoassay systems.

Device Story

Elecsys LH CalSet II is a calibrator for quantitative LH assays on Elecsys immunoassay systems. It consists of a lyophilized human serum matrix containing LH. It is used in clinical laboratory settings by trained personnel to calibrate immunoassay instrumentation. The device ensures the accuracy of LH measurements by providing known concentration levels (low and high) standardized against the 2nd International Standard (NIBSC) 80/552. Healthcare providers use the resulting assay output to assess patient hormonal status. The device is provided in a lyophilized form requiring reconstitution before use.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized human serum matrix containing LH. Standardized against 2nd International Standard (NIBSC) 80/552. Designed for use with Elecsys immunoassay systems.

Indications for Use

Indicated for calibration of quantitative LH assays on Elecsys immunoassay systems. No specific patient population or contraindications described.

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

• Elecsys LH CalSet (K964694)

Submission Summary (Full Text)

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K031299

MAY 12 2003

# 510(k) Summary - Elecsys LH CalSet II

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br><br>Contact person: Theresa M. Ambrose<br><br>Date prepared: April 24, 2003 |
| Device Name | Proprietary name: Elecsys LH CalSet II<br><br>Common name: Calibrator<br><br>Classification name: Calibrator, secondary |
| Device description | Elecsys LH CalSet II consists of a lyophilized human serum matrix with added LH. |
| Intended use | The Elecsys LH CalSet II is used for calibrating the quantitative LH assay on the Elecsys immunoassay systems. |
| Predicate Device | We claim substantial equivalence to the currently marketed Elecsys LH CalSet . (K964694). |

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## 510(k) Summary -- COBAS Integra Creatinine plus ver.2,

continued

The following table compares the Elecsys LH CalSet II and the predicate Reagent Summary device.

| Topic | LH CalSet (K964694) | LHCalSet II (Modified Device) |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys LH CalSet is used<br>for calibrating the quantitative<br>LH assay on the Elecsys<br>1010/2010 and MODULAR<br>ANALYTICS E170<br>immunoassay system. | The Elecsys LH CalSet II is used for<br>calibrating the quantitative LH assay<br>on the Elecsys immunoassay systems. |
| Matrix | Buffer/ protein matrix | Human serum matrix |
| Storage form | Liquid | Lyophilized |
| Levels | Low: approx. 1 mIU/mL<br>High: approx 45 mIU/mL | Same |
| Standardization | Calibrated against 2nd<br>International Standard (NIBSC)<br>80/552 | Same |
| Stability | Unopened at 2-8°C: up to<br>expiration date<br>After opening, in aliquots: 12<br>weeks at 2-8°C<br>Onboard 2010/1010 (20-25 °C):<br>up to 5 hours total<br>E170: use only once | Store at 2-8°C<br>Lyophilized calibrators : up to<br>expiration date<br>Reconstituted: at -20 °C: 1 month<br>(freeze only once)<br>On board: use only once |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 2 2003

Theresa M. Ambrose, Ph.D., FACB Regulatory Principle, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: k031299

> Trade/Device Name: Elecsys LH CalSet II Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: April 24, 2003 Received: May 1, 2003

Dear Dr.Ambrose:

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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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 http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

510(k) Number (if known): N/A

Device Name: Elecsys LH CalSet II

Indications For Use:

The Elecsys LH CalSet II is used for calibrating the quantitative LH assay on the Elecsys immunoassay systems.

Lan Coogs.

(Division Sign-Off)
Division of Clinical Laborator
510(k) Number K031299.

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Concurrence of CDRH, Office of Device Evaluation (ODE) い Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)