25-HYDROXYVITAMIN D 125I RIA KIT

K983617 · DiaSorin, Inc. · LCI · Nov 16, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983617
• Device Name: 25-HYDROXYVITAMIN D 125I RIA KIT
• Applicant: DiaSorin, Inc.
• Product Code: LCI · Clinical Chemistry
• Decision Date: Nov 16, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.2050
• Device Class: Class 1

Intended Use

FOR IN VITRO DIAGNOSTIC USE. This kit intended for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population.

Device Story

The 25-Hydroxyvitamin D 125I RIA Kit is an in vitro diagnostic immunoassay used to quantify 25-hydroxyvitamin D and related metabolites in human serum or plasma. The device functions as a radioimmunoassay (RIA) to assist clinicians in assessing vitamin D sufficiency in adults. It is intended for professional use in clinical laboratory settings. Results are interpreted by clinicians alongside other clinical and laboratory data to inform patient management decisions. The modified device offers improved analytical sensitivity and precision compared to the predicate.

Clinical Evidence

Verification and validation testing performed using patient serum samples. Results demonstrated that the modified device's performance characteristics equaled or surpassed those of the predicate device.

Technological Characteristics

Radioimmunoassay (RIA) test system for quantitative determination of vitamin D metabolites. Utilizes 125I-labeled tracer. Designed for in vitro diagnostic use in clinical laboratories.

Indications for Use

Indicated for quantitative determination of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum or plasma to assess vitamin D sufficiency in adult populations.

Regulatory Classification

Identification

General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

Predicate Devices

• 25-Hydroxyvitamin D 125I RIA Kit (K953567)

Submission Summary (Full Text)

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| | NOV-16-98 MON 03:59 PM<br>NOV 16 1998 | AMERICANSTANDARDDIASORIN | FAX NO. [phone] | | P. 03 |
|--|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-------------------|-------|
| | | Special 510(k); Device Modification (cont.)<br>25-Hydroxyvitamin D 125I RIA Kit | | | |
| | 8. 510(k) Summary | | | November 16, 1998 | |
| | Submitted By: | Judith J. Smith<br>DiaSorin, Inc.<br>9175 Guilford Rd. Suite 100<br>Columbia, MD 21046 | | | |
| | Name Of Device:<br>Trade Name: | 25-Hydroxyvitamin D 125I RIA Kit | | | |
| | Common Name: | Vitamin D Test System | | | |
| | Classification Name: | Vitamin D Test System | | | |
| | Device Classification Class II | | | | |
| | Predicate Device: | 25-Hydroxyvitamin D 125I RIA Kit, K953567, by DiaSorin, Inc. | | | |
| | Device Description:<br>hydroxyvitamin D | Immunoassay kit for quantitative determination of 25- | | | |
| | Intended Use: | FOR IN VITRO DIAGNOSTIC USE.<br>This kit intended for the quantitative determination of 25-<br>hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D<br>metabolites in human serum or plasma to be used in the<br>assessment of vitamin D sufficiency. Assay results should be | | | |

used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population. Technological The modified device has the same technological basis as the Comparison: predicate device.

- The labeling of the modified assay is substantially equivalent to Labeling Comparison: that of the predicate device. Changes in labeling directly reflect the device modification and the resultant improvements in analytical sensitivity and precision.
- Verification and validation testing demonstrated that the Nonclinical Testing: performance characteristics of the modified device equaled or surpassed those of the predicate device.
- Verification and validation testing including the use of patient Clinical Testing: serum samples and demonstrated that the performance characteristics of the modified device equaled or surpassed those of the predicate device.

The modified device is substantially equivalent to the predicate Conclusions from Testing: device and demonstrates improved analytical sensitivity and precision.

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and the comments of the comments of

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NOV

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Judith J. Smith Corporate Director, Worldwide Regulatory Affairs/Quality Systems Diasorin, Inc. 9175 Guilford Rd., Suite 100 Ouarry Park Place Columbia, MD 21046

Re : K983617 25-Hydroxyvitamin D125I RIA Regulatory Class: II Product Code: LCI October 12, 1998 Dated: Received: October 15, 1998

Dear Ms. Smith:

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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ 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 requlation (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 requlations.

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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 acberibed in your sixti. Foot 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 requlation (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" Other general information on your (21 CFR 807.97). 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/dsmamain.html".

Sincerely yours,

Steven Butman

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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Special 510(k): Device Modification (cont.) 25-Hydroxyvitamin D 1251 RIA Kit

3. **Indications for Use**

98361 510(k) Number:

Device Name: 25-Hydroxyvitamin D 125| RIA Kit

Indications For Use:

## FOR IN VITRO DIAGNOSTIC USE.

This kit intended for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population.

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

Concurrence of CDRH, Office of Device Evaluation (ODE).

Prescription Use

(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K983614

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