VITROS CHEMISTRY PRODUCTS CRBM SLIDES

K980283 · Johnson & Johnson Clinical Diagnostics, Inc. · KLT · Feb 25, 1998 · Clinical Toxicology

Device Facts

• Record ID: K980283
• Device Name: VITROS CHEMISTRY PRODUCTS CRBM SLIDES
• Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
• Product Code: KLT · Clinical Toxicology
• Decision Date: Feb 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3645
• Device Class: Class 2

Intended Use

For in vitro diagnostic use only. VITROS CRBM slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma.

Device Story

VITROS Chemistry Products CRBM slides are in vitro diagnostic test slides used to measure carbamazepine concentrations in serum and plasma samples. The device is intended for use in clinical laboratory settings by trained laboratory personnel. The slides utilize a quantitative measurement process to determine drug levels, which assists healthcare providers in monitoring therapeutic compliance, adjusting medication dosages, and identifying potential overdose cases. The output is a quantitative concentration value, which informs clinical decision-making regarding the management of patients undergoing anti-convulsant or mood-stabilizing therapy.

Clinical Evidence

No clinical data provided; device clearance based on substantial equivalence to existing in vitro diagnostic products.

Technological Characteristics

In vitro diagnostic test slides for quantitative measurement of carbamazepine. Designed for use with VITROS Chemistry systems. Principle of operation involves chemical analysis of serum or plasma samples.

Indications for Use

Indicated for the quantitative measurement of carbamazepine (CRBM) concentration in human serum and plasma to monitor patient compliance, therapy, and diagnose potential overdose in patients treated for seizure disorders, trigeminal neuralgia, or manic depressive conditions.

Regulatory Classification

Identification

A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

Submission Summary (Full Text)

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FEB 2 5 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Charles C. Morganson, Jr., RAC Requlatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, New York 14626-5101

K980283 Re : VITROS Chemistry Products CRBM Slides Requlatory Class: لا ت Product Code: KLT Dated: January 23,1998 Received: January 26, 1998

Dear Mr. Morganson:

We have reviewed your Section 510 (k) notification of intent to t 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 aqainst 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. 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 requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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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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.qov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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

Page 1 of 1

510(k) Number (if known): p986253

VITROS Chemistry Products CRBM Slides Device Name:

Indications for Use:

Intended Use:

For in vitro diagnostic use only. VITROS CRBM slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma.

## Summary and Explanation of the Test:

Carbamazepine is a commonly prescribed anti-convulsant used mainly in the treatment of seizure disorders, but is also used to treat trigeminal neuralgia. Carbamazepine has also been useful in the treatment of manic depressive patients as an alternative to lithium therapy. Carbamazepine measurements are used to monitor patient compliance and therapy and to diagnose potential overdose.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K980283 |

| Prescription Use (Per 21 CFR 801.109) | <div style="text-align:center;">✓</div> |
|---------------------------------------|-----------------------------------------|
| OR | Over-The-Counter Use |

(Optional Format 1-2-96)