VITROS CHEMISTRY PRODUCTS PHBR SLIDES

K984288 · Ortho-Clinical Diagnostics, Inc. · DLZ · Jan 26, 1999 · Clinical Toxicology

Device Facts

• Record ID: K984288
• Device Name: VITROS CHEMISTRY PRODUCTS PHBR SLIDES
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: DLZ · Clinical Toxicology
• Decision Date: Jan 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3660
• Device Class: Class 2

Intended Use

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

Device Story

VITROS Chemistry Products PHBR slides are in vitro diagnostic test slides used for the quantitative measurement of phenobarbital in serum and plasma. Used in clinical laboratory settings by trained personnel. The device functions as a chemical assay slide; patient sample is applied to the slide, where a reaction occurs to measure phenobarbital concentration. Results are used by clinicians to monitor therapeutic drug levels, assess patient compliance, and identify potential overdose. The device aids in the management of patients with seizure disorders.

Clinical Evidence

No clinical data provided; device relies on analytical performance characteristics typical of in vitro diagnostic chemistry assays.

Technological Characteristics

In vitro diagnostic test slide for quantitative chemical analysis of phenobarbital. Designed for use with VITROS Chemistry Systems. Operates via colorimetric or similar chemical reaction principles on a slide-based platform. No specific materials or software algorithms described.

Indications for Use

Indicated for the quantitative measurement of phenobarbital in serum and plasma to monitor patient compliance, therapy, and diagnose potential overdose in patients treated for seizure disorders, including tonic-clonic, focal motor, temporal lobe, and febrile seizures.

Regulatory Classification

Identification

A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.

Submission Summary (Full Text)

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JAN 26 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Marlene A. Shulman Regulatory Affairs Associate Ortho-Clinical Diagnostics A•Johnson & Johnson Company 100 Indigo Creek Drive Rochester. New York 14626-5101

Re: K984288 Trade Name: VITROS Chemistry Products PHBR Slides Regulatory Class: II Product Code: DLZ Dated: November 30, 1998 Received: December 1, 1998

Dear Ms. Shulman:

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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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 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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## Statement of Intended Use

Page 1 of 1

510(k) Number (if known): K984288

VITROS Chemistry Products PHBR Slides Device Name:

Indications for Use:

Intended Use:

For in vitro diagnostic use only.

VITROS PHBR slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma.

Summary and Explanation of the Test: Phenobarbital is a commonly prescribed anticonvulsant used mainly in the treatment of seizure disorders and is particularly useful for tonic-clonic, focal motor, temporal lobe, and febrile seizures. Phenobarbital 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)

Than H. Lappala

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

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)