The ARCHITECT iCarbamazepine assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of carbamazepine, an anticonvulsant drug, in human serum or plasma (collected in lithium heparin, sodium heparin, dipotassium EDTA or sodium EDTA tubes) on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.

The ARCHITECT iCarbamazepine Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative measurement of carbamazepine, an anticonvulsant drug, in human serum or plasma.

Device Description

The ARCHITECT iCarbamazepine assay is a one-step immunoassay for the quantitative measurement of carbamazepine in human serum or plasma using CMIA technology with flexible assay protocols referred to as Chemiflex.

In the ARCHITECT iCarbamazepine assay, sample, anti-carbamazepine coated paramagnetic microparticles, and carbamazepine acridinium-labeled conjugate are combined to create a reaction mixture. The anti-carbamazepine coated microparticles bind to carbamazepine present in the sample and the carbamazepine acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of carbamazepine in the sample and the RLUs detected by the ARCHITECT i System optics.

AI/ML Overview

The provided 510(k) summary (K103627) describes the ARCHITECT iCarbamazepine assay, an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of carbamazepine in human serum or plasma.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines analytical performance studies but does not explicitly state specific numerical acceptance criteria for each study (e.g., a required correlation coefficient for linearity or specific CV% for precision). Instead, it lists the types of studies performed to demonstrate substantial equivalence to the predicate device, the AxSYM Carbamazepine assay. The overall conclusion is that the ARCHITECT iCarbamazepine assay "is substantially equivalent to the AxSYM Carbamazepine assay in terms of analytical performance data."

Acceptance Criteria (Stated as study types performed to show equivalence)	Reported Device Performance (Implied as meeting criteria for substantial equivalence)
Precision	Studies demonstrated substantial equivalence to predicate.
Sensitivity (Limit of Blank, Limit of Detection, and Limit of Quantitation)	Studies demonstrated substantial equivalence to predicate.
Linearity	Studies demonstrated substantial equivalence to predicate.
Interferences	Studies demonstrated substantial equivalence to predicate.
Recovery	Studies demonstrated substantial equivalence to predicate.
Manual Dilution	Studies demonstrated substantial equivalence to predicate.
Matrix Comparison (Tube Type)	Studies demonstrated substantial equivalence to predicate.
Method Comparison (Correlation)	Studies demonstrated substantial equivalence to predicate.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample sizes used for the test sets in any of the analytical performance studies.
The document also does not mention the country of origin of the data or whether the studies were retrospective or prospective. These are typically detailed in the full 510(k) submission but are not present in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not refer to "experts" or "ground truth" in the context of clinical interpretation or decision-making, as this is a quantitative immunoassay device. The "ground truth" for this type of device would be established by reference methods or comparison to a legally marketed predicate device, as seen in the "Method Comparison (Correlation)" study. Therefore, the concept of qualified experts establishing ground truth in the way it might apply to image-based diagnostic AI is not relevant here.

4. Adjudication Method for the Test Set:

Not applicable, as the device performs quantitative measurements and does not involve human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices that assist human readers (e.g., radiologists for medical images). The ARCHITECT iCarbamazepine assay is a standalone quantitative measurement device, not an AI assistant for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the studies described are inherently standalone performance evaluations of the ARCHITECT iCarbamazepine assay. The device provides a quantitative measurement of carbamazepine levels directly, without human interpretation of the assay results in the way one would interpret an image. The "Method Comparison (Correlation)" study, for instance, directly compares the device's quantitative output to that of the predicate device.

7. The Type of Ground Truth Used:

For a quantitative diagnostic device like this, the "ground truth" for performance evaluation is typically established through:

Reference methods: Highly accurate and precise methods known to provide true values.
Comparison to a legally marketed predicate device: This is explicitly stated in the document ("Method Comparison (Correlation)") where the ARCHITECT iCarbamazepine assay's results are compared to those of the AxSYM Carbamazepine assay (K935374).
Known concentrations: For studies like linearity, sensitivity, and recovery, samples with precisely known concentrations of the analyte are used.

8. The Sample Size for the Training Set:

The document does not mention a "training set" as this device does not appear to employ machine learning or artificial intelligence in a way that requires a distinct training phase. It is a traditional immunoassay, and its performance is determined by its chemical and mechanical design, not by learning from a dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of a training set for this traditional immunoassay device.

Summary

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510(k) Summary (Summary of Safety and Effectiveness)

K103627

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

OCT 1 4 2011

Applicant Name:

Judith Wallach, Regulatory Affairs Administrator

Regulatory Affairs

Abbott Laboratories Diagnostics Division

Dept. 9V6, AP6C-2

100 Abbott Park Road

Abbott Park, IL 60064

Phone and fax numbers 847-937-1132, FAX 847-937-4836

Date prepared October 12, 2011

Device Name:

Reagent Kit

Classification Name: Carbamazepine test system

Trade Name: ARCHITECT iCarbamazepine

Common Name: Carbamazepine

Governing Regulation: 862.3645

Device Classification: Class II

Classification Panel: Clinical Toxicology

Code: KLT

ARCHITECT iCarbamazepine Calibrator Kit

Classification Name: Calibrators, Drug Specific

Trade Name: ARCHITECT iCarbamazepine

Common Name: Calibrator

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Governing Regulation: 862.3200

Device Classification: Class II

Classification Panel: Clinical Toxicology

Code: DLJ

Legally marketed device to which equivalency is claimed:

AxSYM Carbamazepine (K935374)

Intended Use of the Device

Description of Device

Comparison of Technological Characteristics:

The ARCHITECT iCarbamazepine assay utilizes chemiluminescent microparticle immunoassay (CMIA) technology for the quantitative measurement of carbamazepine, an anticonvulsant drug, in human serum or plasma. The AxSYM Carbamazepine assay utilizes Fluorescence Polarization Immunoassay (FPIA) technology for the quantitative measurement of carbamazepine, an anticonvulsant drug, in serum or plasma.

Summary of Analytical Performance:

The ARCHITECT iCarbamazepine assay is substantially equivalent to the AxSYM Carbamazepine assay in terms of analytical performance data in this 510(k) submission.

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The analytical performance of the ARCHITECT iCarbamazepine assay was demonstrated through the following studies, which are provided in this 510(k) submission:

Precision
· Sensitivity (Limit of Blank, Limit of Detection, and Limit of Quantitation)
· Linearity
Interferences
Recovery
Manual Dilution
· Matrix Comparison (Tube Type)
· Method Comparison (Correlation)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird-like symbol in the center. The text around the circle appears to be the name of an organization or agency. The bird-like symbol is composed of curved lines, giving it a sense of movement or flight. The logo has a simple, clean design, with a focus on conveying a sense of professionalism and purpose.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Abbott Laboratories c/o Ms. Judith Wallach Regulatory Affairs Administrator Dept. 9V6. AP6C-2 100 Abbout Park Road Abbott Park. II. 60064

001 1 4 2011

Re: K103627

Trade/Device Name: Architect iCarbamazepine Immunoassay Regulation Number: 21 CFR 862.3645 Regulation Name: Carbamazepine test system Regulatory Class: Class II Product Code: KLT, DKB Dated: October 12, 2011 Received: October 13. 2011

Dear Ms. Wallach

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, 'Misbranding by reference to premarket notification'' (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding 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 ( 30) ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

signature

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): _ k 1 0 3 4 2 7

Device Name: ARCHITECT iCarbamazepine

Indications for Use:

Reagents :

Calibrators :

X Prescription Use Over-The-Counter Use Preschplion Ose
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Rute Claren

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) (0 3 6 2 ]

Regulation Number and Section

§ 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.