(170 days)
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No
The description details a standard immunoassay technology (CMIA) and its performance characteristics. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is an in vitro diagnostic (IVD) assay used to measure HbA1c levels for monitoring glycemic control in diabetic patients, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section states that "Percent HbA1c measurements are used for monitoring long term glycemic control in diabetic patients," which is a diagnostic purpose to track a patient's health condition.
No
The device description clearly outlines a chemiluminescent immunoassay (CMIA) process involving reagents, magnetic microparticles, and a physical system (ARCHITECT i System) to measure relative light units (RLUs). This involves significant hardware and chemical components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood." This is a measurement performed in vitro (outside the body) on a biological sample (whole blood).
- Purpose: The purpose of the measurement is for "monitoring long term glycemic control in diabetic patients." This is a diagnostic purpose, providing information about a patient's health status.
- Device Description: The description details a laboratory assay (chemiluminescent microparticle immunoassay - CMIA) performed on a biological sample (whole blood) using reagents and a system (ARCHITECT i System). This is characteristic of an in vitro diagnostic device.
- Calibrators: The mention of calibrators further supports its use in a quantitative laboratory assay.
All these elements align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Reagents: The ARCHITECT HbA1c assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood on the ARCHITECT i System. Percent HbA1c measurements are used for monitoring long term glycemic control in diabetic patients.
Calibrators: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent haemoglobin A1c (HbA1c) in human whole blood.
Product codes (comma separated list FDA assigned to the subject device)
JIT, LCP
Device Description
The ARCHITECT HbA1c assay is a two-step pre-treatment immunoassay for the quantitative determination of percent haemoglobin A1c (% HbA1c) in human whole blood using CMIA technology, with flexible assay protocols, referred to as Chemiflex.
Sample is incubated with pre-treatment reagent to lyse the red blood cells. Pre-treated sample is the incubated with magnetic microparticles with a silica surface. Hemaglobin and HbA1c in the sample bind to the silica surface of the microparticles. Following a wash cvcle, anti-HbA1c acridinium-labeled conjugate is added to create a reaction mixture. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs).
The haemoglobin and HbA1c that are bound to the surface of the microparticles represents the total percentage present in the sample however, only the HbA1c result is required to determine the % HbA1c in the sample. A direct relationship exists between the amount of HbA1c in the sample and the RLUs detected by the ARCHITECT i System optics.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The ARCHITECT HbA1c assay demonstrated substantially equivalent performance to the AxSYM HbA1c assay as indicated by a method comparison study, in which a Passing & Bablock method comparison and a Pearson correlation analysis was conducted using 127 samples covering the full measuring range of the assay. The ARCHITECT HbA1c assay demonstrated substantially equivalent performance to the AxSYM HbA1c as indicated in the method comparison study by a slope of 1.04 (95% CI: 0.97 to 1.12), an intercept of -0.07 (95% CI: -0.67 to 0.37) and a correlation coefficient (r) of 0.95 (95% CI: 0.93, 0.96).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The ARCHITECT HbA1c assay is substantially equivalent to the AxSYM HbA1c assay in terms of precision, sensitivity and measurement range (linearity).
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.
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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
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
0
DEC 1 2 2012
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submission correspondent:
Claire Dora Regulatory Affairs Manager Axis-Shield Diagnostics Ltd. The Technology Park Dundee DD2 1XA, Scotland, UK
Device Name: ARCHITECT HbA1c Reagents and ARCHITECT HbA1c Calibrators (A-F).
Reagents:
Regulatory Description: Glycosylated hemoglobin assay Trade Name: ARCHITECT HbA1c Common Name: HbA1c test Governing Regulation: 864.7470 Device Classification: Class II Classification Panel: Hematology Product Code: LCP
Calibrators:
Regulation Description: Calibrator Trade Name: ARCHITECT HbA1c Calibrators (A-F) Common Name: Calibrator Governing Regulation: 862.1150 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: JIT
Legally marketed device to which equivalency is claimed:
AxSYM HbA1c Reagent and AxSYM HbA1c Standard Calibrators (A-F) (K072686)
Architect HbA1c 510(k) Premarket notification submission ADMIN 3.0 510(k) Summary Final v3.0 2012-12-08
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Intended Use of Device:
Reagents:
The ARCHITECT HbA1c assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood on the ARCHITECT i System.
Percent HbA1c measurements are used for monitoring long term glycemic control in diabetic patients.
Calibrators:
The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent haemoglobin A1c (HbA1c) in human whole blood.
Description of Device:
The ARCHITECT HbA1c assay is a two-step pre-treatment immunoassay for the quantitative determination of percent haemoglobin A1c (% HbA1c) in human whole blood using CMIA technology, with flexible assay protocols, referred to as Chemiflex.
Sample is incubated with pre-treatment reagent to lyse the red blood cells. Pre-treated sample is the incubated with magnetic microparticles with a silica surface. Hemaglobin and HbA1c in the sample bind to the silica surface of the microparticles. Following a wash cvcle, anti-HbA1c acridinium-labeled conjugate is added to create a reaction mixture. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs).
The haemoglobin and HbA1c that are bound to the surface of the microparticles represents the total percentage present in the sample however, only the HbA1c result is required to determine the % HbA1c in the sample. A direct relationship exists between the amount of HbA1c in the sample and the RLUs detected by the ARCHITECT i System optics.
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Comparison of Technological Characteristics:
ARCHITECT HbA1c and AxSYM HbA1c are both automated immunoassays for the quantitative determination of percent hemoglobin A1c (HbA1c).
The ARCHITECT and AxSYM systems differ in their detection methods; the ARCHITECT is a chemiluminescent microparticle immunoassay (CMA) whereas the AxSYM is a microparticle enzyme immunoassay (MEIA).
Summary of Non-Clinical Performance:
The ARCHITECT HbA1c assay is substantially equivalent to the AxSYM HbA1c assay in terms of precision, sensitivity and measurement range (linearity) as demonstrated in the non-clinical performance data in this 510(k) submission.
The ARCHITECT HbA1c Calibrators are substantially equivalent to the AxSYM HbA1c Standard Calibrators in terms of intended use, format and % HbA1c levels.
Summary of Clinical Performance:
The ARCHITECT HbA1c assay demonstrated substantially equivalent performance to the AxSYM HbA1c assay as indicated by a method comparison study, in which a Passing & Bablock method comparison and a Pearson correlation analysis was conducted using 127 samples covering the full measuring range of the assay.
The ARCHITECT HbA1c assay demonstrated substantially equivalent performance to the AxSYM HbA1c as indicated in the method comparison study by a slope of 1.04 (95% CI: 0.97 to 1.12), an intercept of -0.07 (95% CI: -0.67 to 0.37) and a correlation coefficient (r) of 0.95 (95% CI: 0.93, 0.96).
Architect HbA1c 510(k) Premarket notification submission ADMIN 3.0 510(k) Summary Final v3.0 2012-12-08
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Axis-Shield Diagnostics Limited c/o Dr. Claire I. Dora Luna Place The Technology Park Dundee, Scotland, UK DD2 1XA, UK
Re: K121842
Trade/Device Name: ARCHITECT HbA1c Reagents ARCHITECT HbAlc Calibrators
Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP, JIT Dated: November 6, 2012 Received: November 8, 2012
Dear Dr. Dora:
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.
December 12, 2012
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Claire Dora
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benson for
Courtney H. Lias, Ph.D.
Director
Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K121842
Device Name:
ARCHITECT HbA1c Reagents and ARCHITECT HbA1c Calibrators.
Indication For Use:
Reagents:
The ARCHITECT HbA1c assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood on the ARCHITECT i System.
Percent HbA1c measurements are used for monitoring long term glycemic control in diabetic patients.
Calibrators:
The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent haemoglobin A1c (HbA1c) in human whole blood.
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 Diagnostics and Radiological Health (OIR)
Rattus Sumus
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health (OIR) Evaluation and Safety
510(k) K121842