(56 days)
Not Found
Not Found
No
The summary provides no information suggesting the use of AI or ML. The device measures a chemical concentration, which is typically done with standard analytical techniques.
No
The device is intended for in vitro diagnostic use to measure phenobarbital concentration in serum and plasma, which is for diagnostic purposes, not therapeutic intervention.
Yes
The "Intended Use / Indications for Use" states "For in vitro diagnostic use only."
No
The 510(k) summary describes VITROS PHBR slides, which are physical slides used for in vitro diagnostic testing. This indicates a hardware component, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only." This is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only.
VITROS PHBR slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma.
Product codes
DLZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3660 Phenobarbital test system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows a partial logo of the Department of Health and Human Services (HHS). The logo features a stylized representation of human figures, with three abstract profiles facing to the right. The word "DEPARTMENT" is partially visible on the left side of the image, oriented vertically.
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 (770) 488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
2
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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)