(117 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
This device is an in vitro diagnostic (IVD) assay used to aid in the diagnosis of vitamin B12 deficiency, not to treat it.
Yes
The intended use explicitly states that the device is "used as an aid in the diagnosis and treatment of vitamin B12 deficiency."
No
The device description clearly outlines a chemiluminescent microparticle immunoassay (CMIA) which involves physical reagents, microparticles, and a system (ARCHITECT i System) to measure relative light units. This is a hardware-based assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of Holotranscobalamin in human serum" and is used "as an aid in the diagnosis and treatment of vitamin B12 deficiency." This clearly indicates it's used to test samples taken from the human body (in vitro) to provide information for medical diagnosis and treatment.
- Device Description: The description details a "chemiluminescent microparticle immunoassay (CMIA)" that analyzes "human serum." This is a laboratory-based test performed on a biological sample outside of the body.
- Performance Studies: The performance studies compare the device to a predicate device that is also an immunoassay, further confirming its nature as a diagnostic test performed on samples.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ARCHITECT Active-B12 (Holotranscobalamin) assay is a chemiluminescent microparticle immunoassay (CMIA) the for quantitative determination of Holotranscobalamin in human serum on the ARCHITECT i System. Active-B12 (Holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency:
The ARCHITECT Active-B12 (Holotranscobalamin) Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of Holotranscobalamin in human serum.
The ARCHITECT Active-B12 (Holotranscobalamin) Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators and instrument) when used for the quantitative determination of Holotranscobalamin in human serum.
Product codes (comma separated list FDA assigned to the subject device)
CDD, JIT, JJX
Device Description
The ARCHITECT Active-B12 (Holotranscobalamin) assay is a two-step immunoassay for the quantitative determination of Holotranscobalamin in human serum using CMIA technology, with flexible assay protocols, referred to as Chemiflex.
In the first step, sample and anti-holotranscobalamin coated paramagnetic microparticles are combined. Holotranscobalamin present in the sample binds to the antiholotranscobalamin coated microparticles. After washing, anti-transcobalamin acridinium-labeled conjugate is added-to create a reaction mixture in the second step. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of Holotranscobalamin 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
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 Active-B12 (Holotranscobalamin) assay demonstrated substantially equivalent performance to the AxSYM Active-B12 (HoloTC) assay as indicated by a method comparison study.
The ARCHITECT Active-B12 (Holotranscobalamin) assay demonstrated substantially equivalent performance to the AxSYM Active-B12 (HoloTC) as indicated by a method comparison with a correlation coefficient (r) of 0.94 (95% confidence interval 0.92, 0.96) for the 125 samples tested and covering the range of 8.13 to 124.43 pmol/L Holotranscobalamin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient (r) of 0.94 (95% confidence interval 0.92, 0.96)
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
§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.
0
112443
DEC 1 9 2011
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:
Dr Claire Dora Regulatory Affairs Manager Axis-Shield Diagnostics Ltd. The Technology Park Dundee DD2 1XA. Scotland, UK
Device Name: ARCHITECT Active-B12 (Holotranscobalamin) Reagents, ARCHITECT Active-B12 (Holotranscobalamin) Calibrators (A-F) and ARCHITECT Active-B12 (Holotranscobalamin) Controls (Low and High).
Reagents:
Classification Name: Vitamin B12 test system Trade Name: ARCHITECT Active-B12 (Holotranscobalamin) Common Name: Holotranscobalamin test Governing Regulation: 862.1810 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: CDD
Calibrators:
Classification Name: Calibrator Trade Name: ARCHITECT Active-B12 (Holotranscobalamin) Calibrators (A-F) Common Name: Calibrator Governing Regulation: 862.1150 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: JIT
Controls:
Classification Name: Quality control material (assayed and unassayed) Architect Active-B12 (Holotranscobalamin) 510(k) Premarket notification submission ADMIN 3.0 510(k) Summary Final v2.0 2011-10-10
1 of 3
1
Trade Name: ARCHITECT Active-B12 (Holotranscobalamin) Control Common Name: Control Governing Regulation: 862.1660 Device Classification: Class I Classification Panel: Clinical Chemistry Product Code: JJX
Legally marketed device to which equivalency is claimed:
AxSYM Active-B12 (HoloTC) Immunoassay (K062467)
Intended Use of Device:
The ARCHITECT Active-B12 (Holotranscobalamin) assay is a chemiluminescent microparticle immunoassay (CMIA) the for quantitative determination of Holotranscobalamin in human serum on the ARCHITECT i System. Active-B12 (Holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency:
Description of Device:
The ARCHITECT Active-B12 (Holotranscobalamin) assay is a two-step immunoassay for the quantitative determination of Holotranscobalamin in human serum using CMIA technology, with flexible assay protocols, referred to as Chemiflex.
In the first step, sample and anti-holotranscobalamin coated paramagnetic microparticles are combined. Holotranscobalamin present in the sample binds to the antiholotranscobalamin coated microparticles. After washing, anti-transcobalamin acridinium-labeled conjugate is added-to create a reaction mixture in the second step. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of Holotranscobalamin in the sample and the RLUs detected by the ARCHITECT i System optics.
Architect Active-B12 (Holotranscobalamin) 510(k) Premarket notification submission ADMIN 3.0 510(k) Summary Final v2.0 2011-10-10
2 of 3
2
Comparison of Technological Characteristics:
ARCHITECT Active-B12 (Holotranscobalamin) and AxSYM Active-B12 (HoloTC) are both automated immunoassays for the quantitative determination of Holotranscobalamin (HoloTC).
The ARCHITECT and AxSYM systems differ in their detection methods; the ARCHITECT is a chemiluminescent microparticle immunoassay (CMIA) whereas the AxSYM is a microparticle enzyme immunoassay (MEIA).
Summary of Non-Clinical Performance:
The ARCHITECT Active-B12 (Holotranscobalamin) assay is substantially equivalent to the AxSYM Active-B12 (HoloTC) assay in terms of precision, calibration, linearity on dilution and specificity as demonstrated in non-clinical performance data in this 510(k) submission.
Summary of Clinical Performance:
The ARCHITECT Active-B12 (Holotranscobalamin) assay demonstrated substantially equivalent performance to the AxSYM Active-B12 (HoloTC) assay as indicated by a method comparison study.
The ARCHITECT Active-B12 (Holotranscobalamin) assay demonstrated substantially equivalent performance to the AxSYM Active-B12 (HoloTC) as indicated by a method comparison with a correlation coefficient (r) of 0.94 (95% confidence interval 0.92, 0.96) for the 125 samples tested and covering the range of 8.13 to 124.43 pmol/L Holotranscobalamin.
Architect Active-B12 {Holotranscobalamin} 510(k) Premarket notification submission ADMIN 3.0 510(k) Summary Final v2.0 2011-10-10
3 of 3
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of curved lines. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Axis-Shield Diagnostics Ltd c/o Dr. Simon Richards The Technology Park Luna Place Dundee, DD2 1XA,UK
DEC 1 9 2011
Re: K112443
Trade Name: ARCHITECT Active-B12 (Holotranscobalamin) Reagents, ARCHITECT Active-B12 (Holotranscobalamin) Calibrators (A-F), ARCHITECT Active-B12 (Holotranscobalamin) Controls (A-F),
Requlation Number: 21/2 (Holotranscobalamin) Controls (Low and High) Regulation Number: 21 CFR §862.1810 Regulation Name: Vitamin B12 test system. Regulatory Class: Class II Product Codes: CDD, JIT, JJX Dated: November 25, 2011 Received: November 29, 2011
Dear Dr. Richards:
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 her lection in the end the marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices marke 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, EDA movemblic be st In addition, FDA may public and art, Coast of Federal Negulations (CFR), Parts 800 to 895.
Register 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 Fequirement 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
4
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely vours.
signature
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known): K112443
Device Name:
Active-B12 (Holotranscobalamin) Reagents, ARCHITECT Active-B12 ARCHITECT (Holotranscobalamin) Calibrators (A-F) and ARCHITECT Active-B12 (Holotranscobalamin) Controls (Low and High)
Indication For Use:
Reagents:
The ARCHITECT Active-B12 (Holotranscobalamin) assay is a chemiluminescent microparticle immunoassay (CMA) for the quantitative determination of Holotranscobalamin in human serum on the ARCHITECT i System. Active-B12 (Holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.
Calibrators:
The ARCHITECT Active-B12 (Holotranscobalamin) Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of Holotranscobalamin in human serum.
Controls:
The ARCHITECT Active-B12 (Holotranscobalamin) Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators and instrument) when used for the quantitative determination of Holotranscobalamin in human serum.
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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112443