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 Description

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.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document provided does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for performance metrics like precision, linearity, and interference. Instead, it uses the phrase "substantially equivalent" to a predicate device (AxSYM® Theophylline II) as the primary measure of a successful evaluation.

Acceptance Criterion (Implied)	Reported Device Performance
Substantially equivalent in precision to predicate device	"The ARCHITECT i Theophylline assay is substantially equivalent to the AxSYM® Theophylline II assay in terms of precision..."
Substantially equivalent in linearity to predicate device	"...linearity..."
Substantially equivalent in interferences to predicate device	"...and interferences as demonstrated in non-clinical performance data in this 510(k) submission."
Substantially equivalent in overall clinical performance to predicate device	"The ARCHITECT i Theophylline demonstrated substantially equivalent performance to the AxSYM® Theophylline II with a correlation coefficient of 0.994."

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

The document does not explicitly state the sample size used for the test set in the clinical performance study. It only mentions the "non-clinical performance data" and "clinical performance" without specifying the number of samples or patients involved.

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

This information is not applicable and not provided in the document. The "ground truth" for a quantitative diagnostic test like theophylline measurement is typically established by comparison to a reference method (in this case, the predicate device results), not by expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods (like 2+1 or 3+1) are typically used when subjective interpretations are involved, such as in imaging studies. For a quantitative immunoassay, the comparison is directly with the results of the predicate method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating human interpretation with and without AI assistance, which is not the nature of this submission for a fully automated immunoassay.

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

Yes, the performance described is a standalone (algorithm only) performance. The ARCHITECT i Theophylline assay is an automated chemiluminescent microparticle immunoassay, meaning its performance is evaluated directly without human interpretation influencing the measurement itself. The comparison is between the new automated system and the existing automated predicate system.

7. The Type of Ground Truth Used

The "ground truth" or reference standard used for comparison was the results obtained from the AxSYM® Theophylline II assay. This is a legally marketed predicate device, and the new device's performance is gauged by its correlation and equivalence to this established method.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For an immunoassay like this, the development process (which could be considered analogous to "training") would involve various experiments for reagent optimization, calibration curve fitting, and assay parameter setting, but these are generally not referred to as a "training set" in the same way as machine learning models. The performance assessment is against clinical samples or spiked samples, but the number of these used for initial method development versus final validation is not detailed.

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

Since a "training set" in the machine learning sense is not explicitly discussed, the concept of establishing ground truth for it is also not addressed. The development of the assay itself would rely on established laboratory practices, analytical standards, and potentially comparison to existing reference methods during its initial R&D phase, leading to the optimized assay parameters and reagents that are then validated against the predicate device.

Summary

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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

Page 1 of 3

510 (K) Summary

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Legally marketed device to which equivalency is claimed:

AxSYM Theophylline II (K953016)

Intended Use of Device:

Description of Device:

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

Page 2 of 3

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

Page 3 of 3

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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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

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

Regulation Number and Section

§ 862.3880 Theophylline test system.

(a)
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.(b)
Classification. Class II.