ELECSYS ESTRADIOL CALSET II

K992981 · Roche Diagnostics Corp. · JIT · Sep 24, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992981
• Device Name: ELECSYS ESTRADIOL CALSET II
• Applicant: Roche Diagnostics Corp.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Sep 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Roche Diagnostics Elecsys® Estradiol CalSet II is intended for the calibration of the quantitative estradiol assay on the Elecsys ® 1010 and 2010 immunoassay systems.

Device Story

Elecsys® Estradiol CalSet II is a calibration product consisting of lyophilized human serum with added estradiol in two concentration ranges. It is used in clinical laboratory settings to calibrate quantitative estradiol assays on Elecsys 1010 and 2010 immunoassay systems. The device provides a reference standard to ensure the accuracy and reliability of estradiol measurements performed by the analyzer. Healthcare providers use the resulting assay output to assess patient hormone levels, aiding in clinical decision-making related to endocrine function and reproductive health.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Lyophilized human serum with added estradiol. Two-level calibration set. Designed for use with Elecsys 1010 and 2010 immunoassay systems. Stability: Unopened stable at 2-8°C until expiration; reconstituted stable at -20°C for 3 months or on-analyzer for 3 hours.

Indications for Use

Indicated for the calibration of quantitative estradiol assays on Elecsys 1010 and 2010 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

• Roche Diagnostics Elecsys® Estradiol CalSet (K965109)

Submission Summary (Full Text)

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SEP 2 4 1999

K992981

# 510(k) Summary – Elecsys® Estradiol CalSet II

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] |
| | Contact person: Priscilla A. Hamill |
| | Date prepared: September 1, 1999 |
| Predicate<br>device | Roche Diagnostics Elecsys® Estradiol CalSet II is substantially equivalent to<br>other devices legally marketed in the United States. We claim equivalence to<br>the currently marketed Roche Diagnostics Elecsys® Estradiol CalSet. |
| Device<br>description | Roche Diagnostics Elecsys® Estradiol CalSet II consists of lyophilized<br>human serum with added estradiol in two concentration ranges. |
| Intended use /<br>Indication for<br>use | Roche Diagnostics Elecsys® Estradiol CalSet II is intended for the calibration<br>of the quantitative estradiol assay on the Elecsys ® 1010 and 2010<br>immunoassay systems. |
| Substantial<br>equivalence | Elecsys® Estradiol CalSet II is equivalent to other devices legally marketed<br>in the United States. We claim equivalence to the currently marketed Roche<br>Diagnostics Elecsys® Estradiol CalSet cleared under document K965109. |

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

The following table compares Elecsys® Estradiol CalSet II, with the Substantial predicate device (currently marketed modified Elecsys® Estradiol CalSet). equivalence similarities

| Characteristic | Elecsys® Estradiol CalSet II<br>(Modified Device) | Elecsys® Estradiol CalSet<br>(Predicate Device) |
|----------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the calibration of the<br>quantitative estradiol assay on<br>the Elecsys 1010 and 2010<br>immunoassay systems. | For the calibration of the<br>quantitative estradiol assay on<br>the Elecsys 1010 and 2010<br>immunoassay systems. |
| Levels | Two levels | Two levels |

### Comparison of Modified Device and Predicate Device

#### Substantial equivalence dífferences —

### Comparison of Modified Device and Predicate Device

| Characteristic | Elecsys® Estradiol CalSet II<br>(Modified Device) | Elecsys® Estradiol CalSet<br>(Predicate Device) |
|----------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Format | Lyophilized | Liquid, ready to use |
| Matrix | Human serum with added<br>estradiol | Buffer/protein |
| Stability | Unopened<br>Stable at 2-8° C until<br>expiration date Reconstituted:<br>✓ -20° - 3 months<br>✓ On analyzer - 3 hours | Unopened<br>Stable at 2-8° C until<br>expiration date Opened<br>✓ 2-8° C – 12 weeks<br>✓ On analyzer - 5 hours |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 4 1999

Ms. Priscilla A. Hamill Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

Re: K992981

> Trade Name: Elecsys® Estradiol CalSet II Regulatory Class: II Product Code: JIT Dated: September 1, 1999 Received: September 3, 1999

Dear Ms. Hamill:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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### Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

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

K99298

Device Name: Elecsys® Estradiol CalSet II

Indications For Use:

For the calibration of the quantitative estradiol assay on the Elecsys 1010 and 2010 immunoassay systems.

Jean Cooper

(D (Sign-Off)
E
of Clinical Laboratory Les
\$16mber K992481

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
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| | | (Optional Format 1-2- |

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