(170 days)
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.
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.
The information provided describes the ARCHITECT HbA1c Reagents and ARCHITECT HbA1c Calibrators, an in-vitro diagnostic device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence to a predicate device (AxSYM HbA1c). Therefore, the "acceptance criteria" are implied to be performance comparable to the predicate device, demonstrated through specific statistical metrics.
| Acceptance Criteria (Implied) | Reported Device Performance (ARCHITECT HbA1c vs. AxSYM HbA1c) |
|---|---|
| Slope close to 1.0 | Slope: 1.04 (95% CI: 0.97 to 1.12) |
| Intercept close to 0 | Intercept: -0.07 (95% CI: -0.67 to 0.37) |
| High Correlation Coefficient | Correlation Coefficient (r): 0.95 (95% CI: 0.93, 0.96) |
| Adequate Sensitivity | Demonstrated "substantially equivalent performance" in sensitivity (no specific numerical criteria or performance for sensitivity reported) |
| Adequate Precision | Demonstrated "substantially equivalent performance" in precision (no specific numerical criteria or performance for precision reported) |
| Adequate Measurement Range | Demonstrated "substantially equivalent performance" in measurement range (linearity) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 127 samples.
- Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a "method comparison study" and does not specify if it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For in-vitro diagnostic devices, the "ground truth" is typically established by comparative analysis against a recognized reference method or a legally marketed predicate device, rather than by human expert review of images or clinical cases.
4. Adjudication Method for the Test Set
This information is not applicable and not provided for this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert interpretation (e.g., radiology studies) to establish a consensus ground truth. Here, the comparison is between two quantitative assays.
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 involves multiple human readers interpreting cases, often with and without AI assistance, and is relevant for devices that aid human interpretation (e.g., in medical imaging). This submission is for an in-vitro diagnostic assay that provides a direct quantitative measurement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance described is a standalone (algorithm only) performance. The ARCHITECT HbA1c assay is an automated chemiluminescent microparticle immunoassay (CMIA) run on the ARCHITECT i System. The performance metrics presented (slope, intercept, correlation) compare the results obtained directly from this automated system against results from the predicate automated system, without any human-in-the-loop interpretation being evaluated.
7. The Type of Ground Truth Used
The "ground truth" in this context is the results obtained from the legally marketed predicate device (AxSYM HbA1c assay). The study is a method comparison, aiming to show that the new device produces results comparable to an already accepted method.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. For an in-vitro diagnostic assay like the ARCHITECT HbA1c, the development process likely involves internal validation and optimization, but the submission primarily details the performance evaluation study against the predicate device.
9. How the Ground Truth for the Training Set Was Established
Since a dedicated "training set" with established ground truth as typically understood in AI/ML contexts is not explicitly mentioned, this information is not provided. The development of the assay itself would have involved establishing accurate calibrators and quality control materials, which form the basis for accurate measurement, but this is distinct from a "ground truth" used for training an AI algorithm.
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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
§ 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).