(238 days)
Not Found
No
The description details a standard immunoassay technology (CMIA) and does not mention any AI or ML components in the assay or the system's operation.
No
The device is an in vitro diagnostic assay used to measure vancomycin levels in patient samples, which aids in diagnosis and treatment monitoring, but it does not directly provide therapy.
Yes
The assay is explicitly stated to be "used in the diagnosis and treatment of vancomycin overdose". Its purpose is to quantify vancomycin levels to aid in medical decision-making.
No
The device is an in vitro diagnostic assay that uses chemical and physical reactions (CMIA technology) to measure vancomycin levels in biological samples. It is designed to be used on a specific hardware system (ARCHITECT i System) and involves physical components like microparticles and reagents, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use."
- Nature of the Assay: The device performs a "quantitative measurement of vancomycin in human serum or plasma." This is a laboratory test performed on biological samples outside of the body, which is the definition of an in vitro diagnostic.
- Purpose of the Assay: The assay is used "in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy." These are clinical purposes directly related to patient care and diagnosis, which is a key characteristic of IVDs.
- Device Description: The description details a "chemiluminescent microparticle immunoassay (CMIA)" performed on the ARCHITECT i System. This is a standard laboratory technique used for in vitro diagnostic testing.
- Calibrators: The description mentions "ARCHITECT iVancomycin Calibrators" which are used for "calibration of the ARCHITECT i System... for the quantitative determination of vancomycin in human serum or plasma." Calibrators are essential components of many in vitro diagnostic assays to ensure accurate measurements.
N/A
Intended Use / Indications for Use
The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT iVancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.
The ARCHITECT iVancomycin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of vancomycin in human serum or plasma.
For in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
LEH, DLJ
Device Description
The ARCHITECT iVancomycin assay is a one-step STAT immunoassay for the quantitative measurement of vancomycin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.
Sample, anti-vancomycin coated paramagnetic microparticles, and vancomycin acridinium-labeled conjugate are combined to create a reaction mixture. The antivancomycin coated microparticles bind to vancomycin present in the sample and to the vancomycin acridinium-labeled conjugate. After washing, pre-trigger and 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 vancomycin in the sample and the RLUs detected by the ARCHITECT i System optics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum or plasma
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 iVancomycin assay is substantially equivalent to the AxSYM Vancomycin II assay in terms of precision, linearity and interferences as demonstrated in non-clinical performance data in this 510(k) submission.
The ARCHITECT iVancomycin demonstrated substantially equivalent performance to the AxSYM Vancomycin II with a correlation coefficient of 0.996.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
AxSYM Vancomycin II (K955851)
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
§ 862.3950 Vancomycin test system.
(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.
0
ARCHITECT Nancomycin
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.
072036 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: vancomycin test system Trade Name: ARCHITECT iVancomycin Immunoassay Common Name: vancomycin test Governing Regulation: 862.3950 Device Classification: Class II Classification Panel: Toxicology Product Code: LEH
Calibrators: Classification Name: Calibrator, drug specific Trade Name: ARCHITECT iVancomycin Calibrators (A-F) Common Name: Calibrator Governing Regulation: 862.3200 Device Classification: Class II Classification Panel: Toxicology Product Code: DLJ
Legally marketed device to which equivalency is claimed:
AxSYM Vancomycin II (K955851)
ARCHITECT Nancomycin 510(K) Submission
Page 1 of 2
510 (K) Summary
1
Intended Use of Device:
The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT iVancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.
Description of Device:
The ARCHITECT iVancomycin assay is a one-step STAT immunoassay for the quantitative measurement of vancomycin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.
Sample, anti-vancomycin coated paramagnetic microparticles, and vancomycin acridinium-labeled conjugate are combined to create a reaction mixture. The antivancomycin coated microparticles bind to vancomycin present in the sample and to the vancomycin acridinium-labeled conjugate. After washing, pre-trigger and 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 vancomycin in the sample and the RLUs detected by the ARCHITECT i System optics.
Comparison of Technological Characteristics:
The ARCHITECT iVancomycin assay is a chemiluminescent microparticle immunoassay (CMIA) method for the quantitative measurement of vancomycin in human serum and The AxSYM® Vancomycin II assay utilizes fluorescence polarization plasma. immunoassay (FPIA) technology for the measurement of vancomycin in serum or plasma.
Summary of Non-Clinical Performance:
The ARCHITECT /Vancomycin assay is substantially equivalent to the AxSYM Vancomycin 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 iVancomycin demonstrated substantially equivalent performance to the AxSYM Vancomycin II with a correlation coefficient of 0.996.
ARCHITECT Nancomycin 510(K) Submission
Page 2 of 2
510 (K) Summary
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 9 2008
Biokit, S.A. Can Male S/N c/o Mr. Joan Guixer Director of Quality Assurance & Regulatory Affairs Llica d'Amunt Barcelona, Spain 08186
Re: K072036 Trade Name: ARCHITECT iVancomycin Reagents and ARCHITECT iVancomycin Calibrators (A-F) Regulation Name: 21 CFR 862.3950 Regulatory Class: Class II Product Codes: LEH, DLJ Dated: March 06, 2008 Received: March 17, 2008
Dear Mr. 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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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 questions 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
4
Indication for Use
510(k) Number (if known):
Device Name: ARCHITECT iVancomycin Reagents and ARCHITECT iVancomycin Calibrators (A-F).
Indication For Use:
Reagents
The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT iVancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.
Calibrators
The ARCHITECT iVancomycin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of vancomycin in human serum or plasma.
For in vitro diagnostic use.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 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)
Carol Benain
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072036
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