(189 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay for measuring phenobarbital levels, with no mention of AI or ML in the device description, performance studies, or key metrics.
No
This device is for in vitro diagnostic use, meaning it's used to test samples outside the body, specifically for quantitative measurement of phenobarbital in human serum or plasma. It helps in diagnosis and monitoring, but it does not directly treat or act upon the body therapeutically.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the assay is for "in vitro diagnostic use" and that "The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy."
No
The device description clearly states it is a "Phenobarbital Assay kit" supplied in liquid form with reagents (Antibody Reagent and Microparticle Reagent) in bottles. This indicates a physical, in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The very first sentence explicitly states "The Abbott Phenobarbital assay is for in vitro diagnostic use". It also describes its use for quantitative measurement in human serum or plasma, which are biological samples tested outside the body.
- Device Description: The description details a kit containing reagents used to perform a test on these biological samples.
- Summary of Performance Studies: The performance studies described (Limit of Quantitation, Precision, Spike Recovery, Method Comparison, etc.) are typical evaluations performed on IVD devices to demonstrate their analytical performance.
- Predicate Device(s): The mention of a predicate device (K993031; Abbott Aerosett Phenobarbital Assay) indicates that this device is being compared to a previously cleared IVD device, which is a common regulatory pathway for IVDs.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Abbott Phenobarbital assay is for in vitro diagnostic use for the quantitative measurement of phenobarbital in human serum or plasma on the ARCHITECT cSystems. The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.
Product codes (comma separated list FDA assigned to the subject device)
DLZ
Device Description
The Phenobarbital Assay kit is supplied ready-to-use in liquid form, for storage at 2 to 8°C. Each Phenobarbital Assay kit is packaged in a rectangular cardboard box divided into three sections. One section will contain three bottles of Antibody Reagent (R1), one section will contain three bottles of Microparticle Reagent (R2), and the last section will contain the package insert. Each kit is sufficient for 300 tests. The configuration is as follows:
| Component | Description | Configuration |
|---|---|---|
| R1 Antibody Reagent |
§ 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
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K123271
Company / Contact Person
Karen Lee Regulatory Affairs Specialist . Thermo Fisher Scientific, Clinical Diagnostics Division 46360 Fremont Blvd. Fremont, CA 94538 Phone: (510) 979-5000 x31814 (510) 979-5422 Fax: E-mail: karen.lee@thermofisher.com
Date Prepared
October 17, 2012
Regulatory Declarations
| Common / Usual Name | Phenobarbital Assay |
|---|---|
| Trade / Proprietary Name | Abbott Phenobarbital Assay |
| Classification Regulation | 21 CFR 862.3660 |
| Device Class | Class II |
| Device Regulation Panel | Toxicology |
| Product Code | DLZ |
Intended Use
Phenobarbital Assay
The Abbott Phenobarbital assay is for in vitro diagnostic use for the quantitative measurement of phenobarbital in human serum or plasma on the ARCHITECT cSystems. The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.
Legally Marketed Device to Which Equivalency is Claimed
The Phenobarbital Assay is substantially equivalent to the previously cleared Abbott Aerosett Phenobarbital Assay (K993031).
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Device Description
The Phenobarbital Assay kit is supplied ready-to-use in liquid form, for storage at 2 to 8°C. Each Phenobarbital Assay kit is packaged in a rectangular cardboard box divided into three sections. One section will contain three bottles of Antibody Reagent (R1), one section will contain three bottles of Microparticle Reagent (R2), and the last section will contain the package insert. Each kit is sufficient for 300 tests. The configuration is as follows:
| Component | Description | Configuration |
|---|---|---|
| R1 Antibody | ||
| Reagent | Trade/Device Name: Abbott Phenobarbital Assay Regulation Number: 21 CFR 862.3660 Regulation Name: Phenobarbital test system Regulatory Class: II Product Code: DLZ Dated: February 27, 2013 Received: March 18, 2013 |
Dear Ms. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K123271
Device Name:
Abbott Phenobarbital Assay
Indications For Use:
The Abbott Phenobarbital assay is for in vitro diagnostic use for the quantitative measurement of phenobarbital in human serum or plasma on the ARCHITECT cSystems. The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.
Prescription Use X AND/OR
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung WDC han-S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K123271 510(k)
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