ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)

K070810 · Biokit, S.A. · LGS · Jun 8, 2007 · Clinical Toxicology

Device Facts

• Record ID: K070810
• Device Name: ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)
• Applicant: Biokit, S.A.
• Product Code: LGS · Clinical Toxicology
• Decision Date: Jun 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3880
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ARCHITECT i Theophylline assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of theophylline in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Theophylline is used in the treatment of bronchospasm associated with bronchial asthma, chronic bronchitis and pulmonary emphysema. The measurements obtained are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to help ensure appropriate therapy. The ARCHITECT i Theophylline Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of theophylline in human serum and plasma.

Device Story

The ARCHITECT i Theophylline assay is a one-step chemiluminescent microparticle immunoassay (CMIA) performed on the ARCHITECT i System. The device processes human serum or plasma samples by combining them with anti-theophylline coated paramagnetic microparticles and theophylline acridinium-labeled conjugate. After a wash step, pre-trigger solutions are added to initiate a chemiluminescent reaction. The system optics measure the resulting relative light units (RLUs). An indirect relationship exists between theophylline concentration in the sample and the detected RLUs. The assay is intended for clinical laboratory use to assist healthcare providers in monitoring therapeutic drug levels and diagnosing potential overdose, thereby helping to ensure appropriate patient therapy.

Clinical Evidence

Clinical performance was evaluated by comparing the ARCHITECT i Theophylline assay to the predicate AxSYM Theophylline II assay. Results demonstrated a correlation coefficient of 0.994. Non-clinical performance data included assessments of precision, linearity, and interferences.

Technological Characteristics

Chemiluminescent microparticle immunoassay (CMIA) technology. Uses anti-theophylline coated paramagnetic microparticles 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 patients requiring theophylline monitoring for treatment of bronchospasm associated with bronchial asthma, chronic bronchitis, and pulmonary emphysema, or for diagnosis/treatment of theophylline overdose.

Regulatory Classification

Identification

A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.

Predicate Devices

• AxSYM Theophylline II assay (k953016)

Submission Summary (Full Text)

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JUN - 8 2007

Ko70810

## ARCHITECT i Theophylline

## 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.

The assigned 510(k) Number is: _______________________________________________________________________________________________________________________________________________

Preparation Date:

## Applicant Name:

Mr. Joan Guixer Director of Quality Assurance and Regulatory Affairs Biokit S.A. Llica d'Amunt Barcelona, Spain 08186

### Device Name:

Reagents Classification Name: Theophylline test system Trade Name: ARCHITECT i Theophylline Immunoassay Common Name: Theophylline test Governing Regulation: 862.3880 Device Classification: Class II Classification Panel: Toxicology Product Code: LGS

Calibrators: Classification Name: Calibrator, Drug Specific Trade Name: ARCHITECT i Theophylline Calibrators (A-F) Common Name: Calibrator Governing Regulation: 862.3200 Device Classification: Class II

Classification Panel: Toxicology

Product Code: DLJ

ARCHITECT i Theophylline 510(K) Submission

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510 (K) Summary

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#### Legally marketed device to which equivalency is claimed:

AxSYM Theophylline II (K953016)

#### Intended Use of Device:

The ARCHITECT i Theophylline assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of theophylline in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Theophylline is used in the treatment of bronchospasm associated with bronchial asthma, chronic bronchitis and pulmonary emphysema. The measurements obtained are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to help ensure appropriate therapy.

The ARCHITECT i Theophylline Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of theophylline in human serum and plasma.

#### Description of Device:

The ARCHITECT iTheophylline assay is a one-step STAT immunoassay for the quantitative determination of theophylline in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.

Sample, anti-theophylline coated paramagnetic microparticles, and theophylline acridinium-labeled conjugate are combined to create a reaction mixture. The antitheophylline coated microparticles bind to theophylline present in the sample and to the theophylline acridinium-labeled conjugate. After washing, pre-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 theophylline in the sample and the RLUs detected by the ARCHITECT / System optics.

#### Comparison of Technological Characteristics:

The ARCHITECT i Theophylline assay is a chemiluminescent microparticle immunoassay (CMIA) method for the quantitative measurement of theophylline in human serum or plasma. The AxSYM ® Theophylline II assay utilizes Flourescence Polarization Immunoassay (FPIA) technology for the measurement of theophylline in serum or plasma.

ARCHITECT / Theophylline 510(K) Submission

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#### 510 (K) Summary

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### Summary of Non-Clinical Performance:

The ARCHITECT i Theophylline assay is substantially equivalent to the AxSYM® Theophylline II 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 i Theophylline demonstrated substantially equivalent performance to the AxSYM® Theophylline II with a correlation coefficient of 0.994.

ARCHITECT / Theophylline 510(K) Submission

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510 (K) Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 8 2007

Biokit S.A. c/o Ms. Joan Guixer Ouality Assurance and Regulatory Affair Director Can Male S/N Llica d'Amunt Barcelona, Spain 08186

Re: k070810

Trade/Device Name: Architect i Theophylline Reagents and Calibrators (A-F) Regulation Number: 21 CFR 862.3880 Regulation Name: Theophylline test system Regulatory Class: Class II Product Code: LGS.DLJ Dated: March 23, 2007 Received: March 27, 2007

Dear Ms. Guixer:

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 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or guestions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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 [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. 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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# ARCHITECT / Theophylline

# Admin 5.0- Product Classification Indications for Use Statement

## 510(k) Number (if known): k070810

Device Name: ARCHITECT i Theophylline Reagents and Calibrators (A-F)

## Indications for Use:

Reagents

The ARCHITECT i Theophylline assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of theophylline in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Theophylline is used in the treatment of bronchospasm associated with bronchial asthma, chronic bronchitis and pulmonary emphysema. The measurements obtained are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to help ensure appropriate therapy.

## Calibrators

The ARCHITECT i Theophylline Calibrators are for the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of theophylline in human serum or plasma.

For in vitro diagnostic use.

Prescription Use X (Part 21 CFR 801 Subpart D) 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 Devices (OIVD)

Carol C. Benson
Division Sign-Off

vision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K070810

ARCHITECT i Theophylline 510(K) Submission

510(K) Indications for Use Statement