(203 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay for measuring carbamazepine levels and does not mention any AI or ML components.
No.
This device is an in vitro diagnostic (IVD) assay used to measure carbamazepine levels in patient samples, which helps monitor therapy. It does not directly treat or diagnose a condition.
Yes
The device is used for the "in vitro quantitative measurement of carbamazepine in human serum or plasma" and "The measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy," which directly indicates its use in diagnostics and monitoring therapeutic levels.
No
The device description clearly states it is a "Carbamazepine Assay kit" supplied in liquid form with bottles of reagents, indicating it is a chemical assay kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is used for the "in vitro quantitative measurement of carbamazepine in human serum or plasma". The term "in vitro" means "in glass" or "in the lab," indicating that the test is performed outside of the living body.
- Sample Type: The assay measures carbamazepine in "human serum or plasma," which are biological samples taken from a patient.
- Purpose: The measurements are used "in monitoring levels of carbamazepine to help ensure appropriate therapy," which is a diagnostic purpose (monitoring drug levels to guide treatment).
These characteristics clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Carbamazepine assay is used for the in vitro quantitative measurement of carbamazepine in human serum or plasma on the ARCHITECT cSystems. The measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.
Product codes (comma separated list FDA assigned to the subject device)
KLT
Device Description
The Carbamazepine Assay kit is supplied ready-to-use in liquid form, for storage at 2 to 8°C. Each Carbamazepine 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: R1 Antibody Reagent
Description:
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
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.(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: K123518
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 Fax: (510) 979-5422 E-mail: karen.lee@thermofisher.com
Date Prepared
November 9, 2012
| Regulatory Declarations | |
|---|---|
| Common / Usual Name | Carbamazepine Assay |
| Trade / Proprietary Name | Abbott Carbamazepine Assay |
| Classification Regulation | 21 CFR 862.3645 |
| Device Class | Class II |
| Device Regulation Panel | Toxicology |
| Product Code | KLT |
Indications For Use
The Carbamazepine assay is used for the in vitro quantitative measurement of carbamazepine in human serum or plasma on the ARCHITECT cSystems. The measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.
Legally Marketed Device to Which Equivalency is Claimed
The Carbamazepine Assay is substantially equivalent to the previously cleared Abbott Aerosett Carbamazepine Assay (K993028).
1
Device Description
The Carbamazepine Assay kit is supplied ready-to-use in liquid form, for storage at 2 to 8°C. Each Carbamazepine 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 | Page 1 of 1 |