ROCHE DIAGNOSTICS ELECSYS AFP CALSET II

K043095 · Roche Diagnostics Corp. · JIT · Nov 23, 2004 · Clinical Chemistry

Device Facts

• Record ID: K043095
• Device Name: ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
• Applicant: Roche Diagnostics Corp.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Nov 23, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

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

Device Story

Elecsys AFP CalSet II; calibrator set for use with Elecsys AFP immunoassay; used to establish calibration curve for quantitative determination of Alpha-fetoprotein (AFP) in human serum/plasma; modification of previously cleared Elecsys AFP CalSet (k981282); changes include matrix shift from buffer to human serum and storage form from liquid to lyophilized; standardized against 1st IRP WHO reference standard 72/225.

Clinical Evidence

No clinical data provided; bench testing only. Stability data provided for storage at 2-8°C, -20°C, and room temperature (20-25°C) to validate the lyophilized formulation.

Technological Characteristics

Lyophilized human serum matrix; two-level concentration (approx. 5-6 ng/ml and 50-60 ng/ml); standardized against 1st IRP WHO 72/225; compatible with Elecsys immunoassay systems.

Indications for Use

Indicated for calibration of quantitative AFP assays on Elecsys immunoassay systems. Intended for prescription 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

• Elecsys® AFP Calset (K981282)

Submission Summary (Full Text)

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NOV 2 3 2004

K043095

## 510(k) Summary - Elecsys® AFP 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<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br>Contact person: Kay A. Taylor<br>Date prepared: November 8, 2004 |
| Device Name | Proprietary name: Elecsys® AFP CalSet II<br>Common name: Calibrator<br>Classification name: Calibratory, secondary |
| Device description | The Elecsys® AFP CalSet II consists of a lyophilized human serum matrix with added AFP in two concentrations. |
| Intended use | The Elecsys AFP CalSet II is used for calibrating the quantitative AFP assay on the Elecsys immunoassay systems. |
| Predicate Device | We claim substantial equivalence to the currently marketed Elecsys® AFP Calset. (K981282). |

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## 510(k) Summary - Elecsys® AFP CalSet II, continued

Reagent Summary The following table describes the similarities and differences between the Elecsys® AFP CalSet II and the Elecsys AFP CalSet.

| Topic | Elecsys® AFP CalSet<br>(K981282) | Elecsys® AFP CalSet II<br>(Modified Device) |
|-----------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys AFP CalSet is used for calibrating the quantitative AFP assay on the Elecsys immunoassay systems. | The Elecsys AFP CalSet II is used for calibrating the quantitative AFP assay on the Elecsys immunoassay systems. |
| Matrix | Buffer | Human serum |
| Storage Form | Liquid | Lyophilized |
| Levels | Low: approx. 5-6 ng/ml<br>High: approx. 50-60 ng/ml | Same |
| Standardization | Standardized against the 1st IRp WHO reference standard 72/225. | Same |
| Stability | 12 wks at 2-8°C:<br>20-25°C: | 6 wks at 2-8°C:<br>6 wks at -20°C: (freeze once)<br>20-25°C: |
| | up to 5 hours on 1010/2010<br>use only once on E170 | up to 5 hours on 1010/2010<br>use only once on E170 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

NOV 2 3 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms Kay Taylor MT (ASCP), RAC Regulatory Program Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: k043095

Trade/Device Name: Roche Diagnostics Elecsys® AFP CalSet II Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: November 8, 2004 Received: November 9, 2004

Dear Ms Taylor:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms Kay Taylor

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 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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,

H.M. Beaty

Robert L. Becker, Jr, M.D., PhD Director Division of Immunology and Hematology Devices

Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

K43095 510(k) Number (if known): N/A

Device Name: Elecsys® AFP CalSet II

Indications For Use:

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

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

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

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)(21 CFR 807 Subpart C) Over-The-Counter Use

Maria In Chan

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Dideler, Clerk-Off

Islon Slan-

Office of In Vitro Diagno ice Evaluation and Safety

510(k) K043095