The Abbott 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.

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.

AI/ML Overview

Here is a summary of the acceptance criteria and the study details for the Abbott Carbamazepine Assay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Functional Sensitivity (LOQ)	Lowest concentration with inter-assay precision CV at ≤ 7%	1.9 µg/mL (Meets design acceptance criteria)
Precision	Total run %CV ≤ 6.3%	Total run %CV ≤ 6.3% (Meets design acceptance criteria)
Spike Recovery	Recovery within ±10% or ±0.4 µg/mL error of HPLC results	All samples recovered within ±10% or ±0.4 µg/mL error of the HPLC results.
Method Comparison (vs. HPLC)	Good correlation expected	Relationship: y = 1.093x + 0.372, R = 0.9584 (n=105) - "correlated well"
Method Comparison (vs. Predicate)	Good correlation with Abbott Aeroset Carbamazepine Assay (K993028) expected	Relationship: y = 0.905x + 0.564, R = 0.9675 (n=103) - "correlated well"
Matrix Comparison	Confirmation of suitability for various matrices	Suitable for use in: serum (glass/plastic), SST (plastic), plasma with sodium fluoride/potassium oxalate (plastic), plasma with sodium heparin (plastic/glass), plasma with lithium heparin (plastic with/without gel), plasma with K3 EDTA (glass/plastic), plasma with K2 EDTA (plastic), and sodium citrate (plastic/glass).
Specificity	Minimal to no cross-reactivity to other medications; minimal to no interference from endogenous substances	Showed minimal to no cross-reactivity to other medications. Showed minimal to no interference to endogenous substances up to tested concentrations.
Linearity	Linear performance throughout the assay range	Performs in a linear fashion from 0.5 to 20 µg/mL.
Onboard Stability	Stable for a specified period on the ARCHITECT cSystem	Reagents stable onboard for up to 45 days.
Standard Curve Calibration Stability	Stable for a specified period on the ARCHITECT cSystem	Standard curve calibration stable for up to 7 days.
Reagent Shelf Life Stability	Stable for a specified period at 2-8°C	Reagents stable at 2-8°C for 24 months.

2. Sample Size and Data Provenance for Test Set

Sample Size for Method Comparison (vs. HPLC): 105 samples
Sample Size for Method Comparison (vs. Predicate): 103 samples
Data Provenance: Not explicitly stated whether retrospective or prospective, nor the country of origin of the data. The context of a 510(k) submission for an in vitro diagnostic usually implies controlled laboratory studies.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This device is an in vitro diagnostic assay, where "ground truth" is typically established by reference methods or instruments rather than expert human interpretation of images/cases.
For the method comparison studies, the "ground truth" was established by comparing the device's results to:
- HPLC (High-Performance Liquid Chromatography): This is a gold standard analytical chemistry technique for quantifying carbamazepine. The document does not specify human experts or their qualifications for interpreting HPLC results; the HPLC itself serves as the reference.
- Abbott Aeroset® Carbamazepine Assay (K993028): This is the legally marketed predicate device, used as a comparative reference.

4. Adjudication Method for the Test Set

Not applicable. As described above, "ground truth" for this type of device is established by instrumental reference methods (HPLC) or comparison to a predicate device, rather than human adjudication of cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI algorithms that assist human readers in making diagnostic interpretations. The Abbott Carbamazepine Assay is an in vitro diagnostic for quantitative measurement of a drug in bodily fluids and does not involve human readers interpreting "cases" in the same way.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance assessment was conducted. The "device performance" metrics listed in the summary (Functional Sensitivity, Precision, Spike Recovery, Method Comparison, Linearity, Stability, etc.) directly reflect the performance of the assay system (reagents plus ARCHITECT cSystems instrument) without human-in-the-loop interpretation. The device's output is a quantitative measurement, not an interpretation requiring human assistance.

7. Type of Ground Truth Used

The ground truth primarily used for evaluating the device's performance was:
- Reference method data (HPLC): For accuracy and recovery studies.
- Predicate device data (Abbott Aeroset® Carbamazepine Assay): For method comparison to demonstrate substantial equivalence.
- Internal analytical standards and controls: For precision, linearity, and stability studies.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" sample size. For an in vitro diagnostic assay, development typically involves extensive characterization and optimization of reagents and assay parameters rather than training a machine learning algorithm with a distinct dataset. The "development" or "optimization" samples are integral to method formulation, but aren't typically referred to as a "training set" in the context of device submission for this type of product.

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

Not applicable / Not explicitly described as a "training set" with established ground truth in the traditional sense. For IVD assays, the process involves calibrating the assay using known concentrations of the analyte (carbamazepine calibrators) that serve as a reference for quantifying unknown samples. These calibrators and controls have precisely defined concentrations, which act as the "ground truth" for establishing the assay's curve and performance characteristics during development and ongoing use. The development process itself ensures the assay yields accurate results against these known standards.

Summary

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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).

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Device Description

Component	Description	Configuration
R1 AntibodyReagent	<1.0% Anti-Carbamazepine monoclonal antibody(mouse) in Bis-Tris buffer and <0.09% sodium azide aspreservative.	3 x 27 mL
R2 MicroparticleReagent	<1.0% Carbamazepine-coated microparticles in Trisbuffer containing <0.09% sodium azide as preservative.	3 x 9 mL

Image /page/1/Figure/3 description: The image shows a kit box with inserts and labels. The kit box contains two RGT sections, labeled R1 and R2, each designed to hold 3 bottles. There are also package inserts within the kit box insert.

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Comparison	Proposed Device	Predicate
ProprietaryName	Abbott Carbamazepine Assay	Abbott Aeroset® Carbamazepine Assay(K993028)
Intended Use	The Carbamazepine assay is used for thein vitro quantitative measurement ofcarbamazepine in human serum or plasmaon the ARCHITECT cSystems.	The assay is intended for use in thequantitative analysis of Carbamazepine inhuman serum or plasma.
Test Principle	The Carbamazepine assay is ahomogeneous particle-enhancedturbidimetric inhibition immunoassay(PETINIA) used for the analysis ofcarbamazepine in serum or plasma. Theassay is based on competition betweendrug in the sample and drug coated onto amicroparticle for antibody binding sites ofthe carbamazepine antibody reagent. Thecarbamazepine-coated microparticlereagent is rapidly agglutinated in thepresence of the anti-carbamazepineantibody reagent and in the absence of anycompeting drug in the sample. The rate ofabsorbance change is measuredphotometrically, and is directly proportionalto the rate of agglutination of the particles.When a sample containing carbamazepineis added, the agglutination reaction ispartially inhibited, slowing down the rate ofabsorbance change. A concentration-dependent classic agglutination inhibitioncurve can be obtained, with maximum rateof agglutination at the lowestcarbamazepine concentration and thelowest agglutination rate at the highestcarbamazepine concentration.	The Carbamazepine assay is ahomogeneous enzyme immunoassaytechnique used for the analysis ofcarbamazepine in biological fluids. Theassay is based on competition for antibodybinding sites between the analyte drug inthe specimen and exogenous drug labeledwith the enzyme glucose-6-phosphatedehydrogenase (G6PDH). Since G6PDHactivity decreases upon binding to theantibody, the concentration of drug in thespecimen can be measured in terms ofenzyme activity. Active G6PDH reducesnicotinamide adenine dinucleotide (NAD) toNADH, resulting in an absorbance changethat is measured spectrophotometrically.Endogenous serum G6PDH does notinterfere because the coenzyme NADfunctions only with the bacterial(Leuconostoc mesenteroides) enzymeemployed in the assay.
Sample Matrix	Human Serum or Human Plasma	Human Serum or Human Plasma
Reagent	Liquid Ready-to-Use (Antibody reagent,Carbamazepine-coated microparticlereagent)	Liquid Ready-to-Use (Antibody reagent,Carbamazepine-labeled enzyme reagent)
Storage	2-8°C	2-8°C
Calibrator	Liquid Ready-to-Use, six levels (0.0, 2.0,4.0, 8.0, 12.0, and 20.0 µg/mL)	Liquid Ready-to-Use, six levels (0.0, 2.0,4.0, 8.0, 12.0, and 20.0 µg/mL)
Assay Range	1.9 to 20.0 µg/mL	0.5 to 20.0 µg/mL

		Comparison of Technological Characteristics
--	--	---------------------------------------------

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Summary of Performance Testing

Functional Sensitivity (LOQ)

Limit of Quantitation (LOQ) determines the lowest concentration which results a CV of inter assay precision at 7% that has been measured over an extended period. The results demonstrate that the LOQ is 1.9 µg/mL and meet design acceptance criteria.

Precision

Carbamazepine samples tested for precision following a CLSI protocol. In the study, the total run %CV was less than or equal to 6.3% and meets design acceptance criteria.

Spike Recovery

Neqative serum samples were spiked with carbamazepine at concentrations across the assay range. All of the samples recover within ±10% or ±0.4 µg/mL error of the HPLC results.

Method Comparison

Samples were tested in the Carbamazepine Assay and compared to HPLC and Aeroset Carbamazepine Assay (K993028). The assay correlated well with HPLC as follows: y = 1.093x + 0.372, R = 0.9584, n=105. The assay also correlated well with the Aeroset Carbamazepine Assay as follows: y = 0.905x + 0.564, R = 0.9675, n = 103.

Matrix Comparison

The following matrices were tested and may be suitable for use in the Carbamazepine Assay: serum in glass. serum in plastic, serum separator tube (SST) in plastic, plasma with sodium fluoride/potassium oxalate in plastic, plasma with sodium heparin in plastic and glass, plasma with lithium heparin in plastic with or without gel, plasma with K3 EDTA in glass and plastic, plasma with K2 EDTA in plastic, and sodium citrate in plastic and glass.

Specificity

The assay showed minimal to no cross reactivity to other medications potentially administered with carbamazepine. The assay also showed minimal to no interference to endogenous substances up to the concentrations tested.

Linearity

Samples were tested to demonstrate linearity throughout the assay range. Results demonstrate that the assay performs in a linear fashion from 0.5 to 20 µg/mL.

Onboard Stability

Using the Abbott Architect cSystem, the reagents were stable onboard for up to 45 days.

Standard Curve Calibration Stability

Using the Abbott Architect cSystem, the standard curve calibration was stable for up to 7 days.

Reagent Shelf Life Stability

Studies showed that the reagents will be stable at 2-8°C for 24 months.

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Conclusion

Substantial equivalence of the Abbott Carbamazepine Assay to the previously cleared Abbott Aeroset® Carbamazepine Assay (K993028) has been demonstrated through performance testing (Section 18) to verify that the device functions as intended and design specifications have been satisfied.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the logo is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 5, 2013

Microgenics Corporation C/O Ms. Karen Lee 46360 Fremont Blvd. FREMONT CA 94538

Re: K123518

Trade/Device Name: Abbott Carbamazepine Assay Regulation Number: 21 CFR 862.3645 Regulation Name: Neuroleptic drugs radioreceptor assay test system Regulatory Class: II Product Code: KLT Dated: April 26, 2013 Received: April 30, 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.

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/CDRHQffices/ucm115809.htm for

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Page 2-Ms. Lee

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.l11m 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 Statement

510(k) Number (if known)

K123518

Device Name

Abbott Carbamazepine Assay

Indications For Use

Prescription Use X AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)

Denise Johnson-lyles -S 2013.06.04 09:54:12 -04'00'

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K123518

Page 1 of 1

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.