ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35

K090358 · Abbott Laboratories, Inc. · LEG · Aug 6, 2009 · Clinical Toxicology

Device Facts

• Record ID: K090358
• Device Name: ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35
• Applicant: Abbott Laboratories, Inc.
• Product Code: LEG · Clinical Toxicology
• Decision Date: Aug 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3645
• Device Class: Class 2

Intended Use

The ARCHITECT iValproic Acid assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of valproic acid, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of valproic acid to help ensure appropriate therapy. The ARCHITECT iValproic Acid Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of valproic acid in human serum or plasma.

Device Story

The ARCHITECT iValproic Acid assay is a one-step STAT in vitro diagnostic immunoassay performed on the ARCHITECT i System. It utilizes chemiluminescent microparticle immunoassay (CMIA) technology. Input consists of human serum or plasma samples. The assay combines samples with anti-valproic acid coated paramagnetic microparticles and valproic acid acridinium-labeled conjugate. After a wash step, pre-trigger and trigger solutions are added to initiate a chemiluminescent reaction. The system optics measure the resulting relative light units (RLUs). The concentration of valproic acid is inversely proportional to the detected RLUs. The device is intended for use in clinical laboratory settings by trained personnel. Results are used by clinicians to monitor therapeutic drug levels and adjust patient treatment as necessary.

Clinical Evidence

Clinical performance was evaluated by comparing the ARCHITECT iValproic Acid assay to the predicate AxSYM Valproic Acid assay. The study demonstrated a correlation coefficient of 0.986, indicating substantial equivalence in performance.

Technological Characteristics

Chemiluminescent Microparticle Immunoassay (CMIA) technology. Uses paramagnetic microparticles coated with anti-valproic acid and acridinium-labeled conjugate. Operates on the ARCHITECT i System with STAT protocol capability. Quantitative measurement based on chemiluminescent reaction measured as relative light units (RLUs).

Indications for Use

Indicated for the quantitative measurement of valproic acid in human serum or plasma to monitor drug levels and ensure appropriate therapy in patients receiving anticonvulsant treatment.

Regulatory Classification

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.

Predicate Devices

• AxSYM Valproic Acid assay (k941615)

Submission Summary (Full Text)

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K090358

AUG 0 6 2009

#### ARCHITECT iValproic Acid

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

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.

## Applicant Name:

Judi Wallach

Regulatory Affairs Specialist

Abbott Laboratories

100 Abbott Park Road

Abbott Park, IL 60064

#### Device Name:

### Reagents:

Classification Name: Valproic Acid test system Trade Name: ARCHITECT iValproic Acid Immunoassay Common Name: Valproic Acid test Governing Regulation: 862.3645 Device Classification: Class II Classification Panel: Toxicology Product Code: LEG

#### Calibrators:

Classification Name: Calibrator, drug specific Trade Name: ARCHITECT iValproic Acid Calibrators (A-F) Common Name: Calibrator Governing Regulation: 862.3200 Device Classification: Class II Classification Panel: Toxicology Product Code: DLJ

ARCHITECT iValproic Acid 510(k) Submission

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## Legally marketed device to which equivalency is claimed:

AxSYM Valproic Acid (K941615)

#### Intended Use of Device:

The ARCHITECT iValproic Acid assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of valproic acid, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of valproic acid to help ensure appropriate therapy.

### Description of Device:

The ARCHITECT iValproic Acid assay is a one-step STAT immunoassay for the quantitative measurement of valproic acid in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. Sample, antivalproic acid coated paramagnetic microparticles, and valproic acid acridiniumlabeled conjugate are combined to create a reaction mixture. The anti-valproic acid coated microparticles bind to valproic acid present in the sample and to the valoroic acid acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is mcasured as relative light units (RLUs). An indirect relationship exists between the amount of valproic acid in the sample and the RLUs detected by the ARCHITECT i System optics.

## Comparison of Technological Characteristics:

The ARCHITECT iValproic Acid assay utilizes Chemiluminescent Microparticle Immunoassay (CMIA) technology for the quantitative measurement of valproic acid, an anticonvulsant drug, in human serum and plasma. The AxSYM Valproic Acid assay utilizes Fluorescence Polarization Immunoassay (FPIA) technology for the quantitative measurement of valproic acid, an anticonvulsant drug, in serum or plasma.

ARCHITECT iValproic Acid 510(k) Submission

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# Summary of Non-Clinical Performance:

The ARCHITECT iValproic Acid assay is substantially equivalent to the AxSYM Valproic Acid assay in terms of precision, linearity, and interferences as demonstrated in non-clinical performance data in this 510(k) submission.

# Summary of Clinical Performance:

The ARCHITECT iValproic Acid assay demonstrated substantially equivalent performance to the AxSYM Valproic Acid assay with a correlation coefficient of 0.986.

ARCHITECT íValproic Acid 510(k) Submission

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle, with its wings spread and its head turned to the left.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Abbott Laboratories Inc., Diagnostic Division c/o Ms. Judi Wallach Senior Regulatory Affairs Specialist 100 Abbott Park Road, AP6C-2, Dept 049C Abbott Park, IL 60064

Re: k090358

Trade Name: Architect iValproic Acid Immunoassay and Architect iValproic Acid Calibrators (A-F)

AUG 0 62009

Regulation Number: 21 CFR §862.3645

Regulation Name: Neuroleptic Drugs Radioreceptor Assay Test System Regulatory Class: Class II Product Codes: LEG, DLJ Dated: June 24, 2009 Received: June 25, 2009

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) 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 [phone]. 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 [phone]. 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 [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

G.C.H

Courtney C. Harper, Ph.D. Acting 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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### Indication for Use

510(k) Number (if known):

Device Name: ARCHITECT iValproic Acid

Indication for Use:

#### Reagents

The ARCHITECT iValproic Acid assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of valproic acid, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The mcasurements obtained are used in monitoring levels of valproic acid to help ensure appropriate therapy.

#### Calibrators

The ARCHITECT iValproic Acid Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of valproic acid in human serum or plasma.

Prescription Use -X (Part 21 CFR 801 Subpart D)

And/Or

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Concurrence of SBDRR, Office of

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

510(k) k090358