(105 days)
Not Found
No
The description details a standard immunoassay using chemiluminescent technology and antibodies, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an in vitro diagnostic (IVD) assay used to measure holotranscobalamin, which aids in the diagnosis and treatment of vitamin B12 deficiency, but it is not itself a therapeutic device that treats or cures a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is "for in vitro diagnostic use" and that "Active-B12 (holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency."
No
The device description clearly indicates it is a fully automated immunoassay using chemiluminescent technology with physical reagents (Lite Reagent, Solid Phase with magnetic latex microparticles), which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states, "The ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) assay is for in vitro diagnostic use..." This is the most direct indicator.
- Device Description: The description details a laboratory assay that measures a substance (holotranscobalamin) in a biological sample (human serum) using chemical and immunological methods. This is characteristic of an in vitro diagnostic device.
- Intended User/Care Setting: While not explicitly stating a specific user like a lab technician, the "in vitro diagnostic use" implies use in a laboratory or clinical setting where such tests are performed.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) assay is for in vitro diagnostic use in the quantitative measurement of holotranscobalamin (holoTC) in human serum using the ADVIA Centaur XP system. Active-B12 (holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.
Product codes
CDD
Device Description
The ADVIA Centaur AB12 assay is a fully automated, two-step direct immunoassay using chemiluminescent technology. The assay utilizes an acridinium ester-labeled anti-transcobalamin antibody as the Lite Reagent. The Solid Phase consists of biotinylated anti-holotranscobalamin antibody coupled to streptavidin-coated magnetic latex microparticles.
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
Prescription Use
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)
Verification, validation and testing activities were conducted to establish performance of the modified device, which included: Accuracy by correlation, Dilution Linearity, 20-day precision – repeatability and within-run, Detection capability - Limit of blank / detection / quantification, Dilution recovery of WHO IRP (NIBSC 03/178), Proficiency sample testing, Reference range / expected value for asymptomatic population. The device passed all of the tests based on pre-determined Pass/Fail criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 27, 2017
AXIS-SHIELD DIAGNOSTICS LTD. CLAIRE DORA REGULATORY AFFAIRS MANAGER LUNA PLACE THE TECHNOLOGY PARK DUNDEE, SCOTLAND DD2 1XA UK
Re: K172133
Trade/Device Name: ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) assay Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: II Product Code: CDD Dated: September 26, 2017 Received: September 28, 2017
Dear Dr. Claire 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 Parts 801 and 809); 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
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kellie B. Kelm -S
Courtney H. Lias, Ph.D. for 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) K172133
Device Name
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) assay
Indications for Use (Describe)
The ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) assay is for in vitro diagnostic use in the quantitative measurement of holotranscobalamin (holoTC) in human serum using the ADVIA Centaur XP system. Active-B12 (holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
The assigned 510(k) number is K172133
Submission correspondent:
Dr Claire Dora Regulatory Affairs Manager Axis-Shield Diagnostics Ltd. The Technology Park Dundee, DD2 1XA, Scotland, UK Telephone: +44(0) 1382 422000 Fax: +44(0) 1382 422088 510k summary prepared date: 25th October 2017
Device Name:
ADVIA Centaur® Active-B12 (Holotranscobalamin) (AB12) Assay
Reagents:
Classification Name: Vitamin B12 test system Trade Name: ADVIA Centaur® Active-B12 (Holotranscobalmin) (AB12) assay Common Name: B12 test Governing Regulation: 21CFR 862.1810 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: CDD
Legally marketed device to which equivalency is claimed:
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) assay, K160757
Intended Use of Device:
The ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) assay is for in vitro diagnostic use in the quantitative measurement of holotranscobalamin (holoTC) in human serum using the ADVIA Centaur XP system. Active-B12 (holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.
Description of Device:
Centaur AB12 assay is a fully automated, two-step direct immunoassay The ADVIA using chemiluminescent technology. The assay utilizes an acridinium ester-labeled anti-transcobalamin antibody as the Lite Reagent. The Solid Phase consists of biotinylated anti-holotranscobalamin antibody coupled to streptavidin-coated magnetic latex microparticles.
Comparison of Technological Characteristics:
The modified ADVIA Centaur AB12 assay is being compared to the cleared ADVIA Centaur AB12 assay (K160757) for the quantitative measurement of holotranscobalamin (holoTC) in human serum.
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Modification of Device:
The special 510k modification ADVIA Centaur AB12 assay consisted of a change to the calibration to be traceable to the WHO International Standard for Holotranscobalamin.
Comparison of the subject device with the predicate device:
The modified ADVIA Centaur® AB12 assay is being compared to the cleared ADVIA Centaur® AB12 assay (K160757).
| Parameter | NEW
ADVIA Centaur®AB12
(Modified Device) | PREDICATE
ADVIA Centaur®AB12
(K160757 cleared device) |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Same | For in vitro diagnostic use in the quantitative
measurement of holotranscobalamin (holoTC) in
human serum using the ADVIA Centaur XP system.
Active-B12 (holotranscobalamin) is used as an aid in
the diagnosis and treatment of vitamin B12
deficiency. |
| Assay Technology /
System | Same | Chemiluminescent microparticle
immunoassay ADVIA Centaur XP/XPT system |
| Reagents | Same | Lite Reagent:
anti-transcobalamin (TC) monoclonal Ab 3-11
(0.5 µg/mL) labeled with acridinium ester in
buffer with surfactant and preservatives
Solid Phase Reagent:
streptavidin coated paramagnetic mP
preformed with biotinylated anti-holoTC
monoclonal antibody 3C4
(~0.4 mg/mL) in buffer with surfactant |
| Calibration | Same | 2-point Calibration using 2 level calibrators |
| Calibration Range | Same | 0 to 146.0 pmol/L |
| Calibration Frequency | Same | 44 days |
| Levels | Same | 2 Levels
Low – 19 pmol/L
High - 121 pmol/L |
| Fill volume | Same | 4.0 mL |
| Calibration Materials
Formulation/ Matrix | Same | recombinant holotranscobalamin, bovine
serum albumin and sodium azide (