VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS

K974644 · Johnson & Johnson Clinical Diagnostics, Inc. · JJX · Jan 13, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974644
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
• Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Free T4, Estradiol, CK-MB and Ferritin.

Device Story

VITROS Immunodiagnostic Products Range Verifiers are in vitro diagnostic reagents used to verify the calibration range of the VITROS Immunodiagnostic System. These verifiers are utilized by laboratory professionals to ensure the accuracy and linearity of the system's measurement range for specific immunoassays, including Free T4, Estradiol, CK-MB, and Ferritin. By confirming that the system's response remains within the established calibration limits, the device assists clinicians in maintaining the reliability of patient test results, thereby supporting accurate clinical decision-making and patient management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent kit for calibration verification. Designed for use with the VITROS Immunodiagnostic System. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for in vitro verification of calibration range on the VITROS Immunodiagnostic System for specific immunoassays including Free T4, Estradiol, CK-MB, and Ferritin. Intended for professional clinical laboratory use.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 3 1998

Ann Quinn Manager, Regulatory Affairs Johnson & Johnson Clinical Diagnostics, Inc. 100 Indigo Creek Rochester, New York 14650

K974644 Re : VITROS Immunodiagnostic Products Range Verifiers Requlatory Class: I Product Code: JJX Dated: December 11, 1997 December 12, 1997 Received:

Dear Ms. Quinn:

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, Druq, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. 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 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 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 Other general premarket notification" (21 CFR 807.97). 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/dsmamain.html".

Sincerely yours,
Steven Gutman

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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## Statement of Intended Use (Appendix C)

| 510(k) Number (if known): | Page 1 of 1 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VITROS Immunodiagnostic Products Range Verifiers |
| Indications for Use: | For in vitro use in verifying the calibration range of the VITROS<br>Immunodiagnostic System when used for the measurement of<br>immunoassays which include Free T4, Estradiol, CK-MB and<br>Ferritin. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | (Division Sign-Off) |
|--|---------------------|
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Division of Clinical Laboratory Devices,

| 510(k) Number | K974644 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(Per 21 CFR 801.109) | <span style="text-decoration: underline;">✓</span> |
|------------------------------------------|----------------------------------------------------|
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OR

| Over-The-Counter Use | <span style="text-decoration: underline;"></span> |
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(Optional Format 1-2-96)ﺮ