(74 days)
Not Found
No
The description details a standard immunoassay technology (CMIA) and does not mention any AI or ML components in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No.
This device is an in vitro diagnostic immunoassay used to measure theophylline levels in human serum or plasma, which aids in diagnosing and treating theophylline overdose or monitoring drug levels for appropriate therapy. It does not directly treat a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements obtained from this device are "used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to help ensure appropriate therapy," which clearly indicates a diagnostic purpose.
No
The device description clearly outlines a chemiluminescent microparticle immunoassay (CMIA) which involves physical reagents (microparticles, conjugate, solutions) and a system (ARCHITECT i System) that measures relative light units. This is a hardware-based in vitro diagnostic device, not software-only.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is "in vitro" and is used for the "quantitative measurement of theophylline in human serum or plasma." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body.
- Device Description: The description details how the assay works by combining sample (serum or plasma) with reagents and measuring a reaction. This process is performed outside of the body, which is characteristic of an IVD.
- Performance Studies: The performance studies compare the device to a predicate device (AxSYM® Theophylline II) which is also an IVD. This further supports the classification.
The text clearly indicates that this device is used to analyze biological samples (serum or plasma) outside of the body to provide diagnostic information (theophylline levels for diagnosis and treatment monitoring).
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LGS, DLJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The ARCHITECT i Theophylline demonstrated substantially equivalent performance to the AxSYM® Theophylline II with a correlation coefficient of 0.994.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient of 0.994
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
Page 2 of 3
510 (K) Summary
2
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
3
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).
4
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
5
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
ARCHITECT i Theophylline 510(K) Submission
510(K) Indications for Use Statement