ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01

K082953 · Biokit, S.A. · KXT · Dec 22, 2008 · Clinical Toxicology

Device Facts

• Record ID: K082953
• Device Name: ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
• Applicant: Biokit, S.A.
• Product Code: KXT · Clinical Toxicology
• Decision Date: Dec 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

The ARCHITECT iDigoxin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of digoxin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used to aid in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy. The ARCHITECT iDigoxin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of digoxin in human serum or plasma. For in vitro diagnostic use

Device Story

ARCHITECT iDigoxin is an in vitro chemiluminescent microparticle immunoassay (CMIA) for quantitative digoxin measurement in human serum or plasma. Used on ARCHITECT i System with STAT protocol. Principle: one-step competitive immunoassay; sample, antidigoxin-coated paramagnetic microparticles, assay diluent, and digoxigenin acridinium-labeled conjugate combined. Microparticles bind to digoxin in sample and labeled conjugate. After washing, pre-trigger solutions added; chemiluminescent reaction measured as relative light units (RLUs). Indirect relationship between digoxin concentration and RLUs. Operated by laboratory personnel in clinical settings. Output used by clinicians to assess digoxin toxicity and therapeutic levels, aiding clinical decision-making for patient treatment.

Clinical Evidence

Clinical performance demonstrated via method comparison against predicate Aeroset Multigent Digoxin. Study yielded a Pearson correlation coefficient of 0.993. Non-clinical data included precision, linearity, and interference testing.

Technological Characteristics

Chemiluminescent microparticle immunoassay (CMIA). Components: antidigoxin-coated paramagnetic microparticles, digoxigenin acridinium-labeled conjugate. Detection: chemiluminescence measured as relative light units (RLUs). Platform: ARCHITECT i System. In vitro diagnostic use.

Indications for Use

Indicated for quantitative measurement of digoxin in human serum or plasma to aid in diagnosis/treatment of digoxin overdose and monitoring therapy levels. No specific age or gender restrictions provided; contraindications include use of antibody fragment therapy (e.g., DIGIBIND) which interferes with immunoassay measurements.

Regulatory Classification

Identification

A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Predicate Devices

• Aeroset Multigent Digoxin (k023058)

Submission Summary (Full Text)

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DEC 2 2 2008

# ARCHITECT iDigoxin

## 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: 10 82953

Preparation Date:

# Applicant Name:

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

## Device Name:

Reagents Classification Name: digoxin test system Trade Name: ARCHITECT iDigoxin Immunoassay Common Name: digoxin test system Governing Requlation: 862.3320 Device Classification: Class II Classification Panel: Toxicology Product Code: KXT

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

Legally marketed device to which equivalency is claimed: Aeroset Multigent Digoxin (k023058)

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# Intended Use of Device:

The ARCHITECT /Digoxin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of digoxin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used to aid in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy.

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

## Description of Device:

The ARCHITECT iDigoxin assay is a one-step STAT immunoassay for the quantitative measurement of digoxin in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. Sample, antidigoxin coated paramagnetic microparticles, assay diluent, and digoxiqenin acridinium-labeled conjugate are combined to create a reaction mixture. The antidigoxin coated microparticles bind to digoxin present in the sample and to the digoxigenin 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 digoxin in the sample and the RLUs detected by the ARCHITECT i System optics.

## Comparison of Technological Characteristics:

The ARCHITECT Digoxin assay is a chemiluminescent microparticle immunoassay (CMIA) method for the quantitative measurement of of digoxin in human serum or plasma. The Aeroset Multigent Digoxin assay is a homogeneous particle-enhanced turbidimetric immunoassay (PETIA) used for the analysis of digoxin in serum or plasma.

## Summary of Non-Clinical Performance:

The ARCHITECT iDigoxin assay is substantially equivalent to the Aeroset Multigent Digoxin 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 iDigoxin demonstrated substantially equivalent performance to the Aeroset Multigent Digoxin with a Pearson correlation coefficient of 0.993.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 2 2008

BioKit S.A. c/o Mr. John Guixer Quality Assurance and Regulatory Affairs Director Can Malé s/n Lliçà d'Amunt, Barcelona, 08186, Spain

Re: k082953

Trade Name: Architect iDigoxin Reagents, Architect iDigoxin Calibrator Regulation Number: 21 CFR 862.3320 Regulation Name: Digoxin Test System. Regulatory Class: Class II Product Codes: KXT, DLJ Dated: September 30, 2008 Received: October 06, 2008

Dear Mr. Guixer:

We have reviewed your Scction 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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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 10gally marketed predicate device results in a classification for your device and thus, rerroits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions 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 trom the [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.

Yéan 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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# Indication for Use

510(k) Number (if known):

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

#### Indication for Use:

#### Reagents

The ARCHITECT iDigoxin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of digoxin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used to aid in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy.

#### Calibrators

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

For in vitro diagnostic use.

Prescription Use × (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 Bensen
Sign-Off

്ce of In Vitro Diagnostic Device ation and Safety

K082953_