(90 days)
K#030655
Not Found
No
The device description details a standard immunoassay process and the performance studies compare it to a radioimmunoassay. There is no mention of AI, ML, or any computational methods beyond standard data processing for quantitative results.
No
The device is an in vitro diagnostic (IVD) assay designed to detect HoloTC, which is used as an aid in the diagnosis and treatment of vitamin B12 deficiency. It does not directly treat or provide therapy to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states, "HoloTC is used as an aid in the diagnosis and treatment of vitamin B12 deficiency," and "For in vitro diagnostic use."
No
The device description clearly outlines a Microparticle Enzyme Immunoassay (MEIA) technology that involves physical reagents, pipetting steps, reaction vessels, and a Matrix Cell. This indicates a hardware-based in vitro diagnostic system, not a software-only device.
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 Test: The device performs a quantitative determination of holotranscobalamin (HoloTC) in human serum and plasma. This is a laboratory test performed on biological samples outside of the body, which is the definition of an in vitro diagnostic test.
- Purpose: The test is used as an aid in the diagnosis and treatment of vitamin B12 deficiency, indicating a medical purpose for the results obtained from the test.
- Components: The description includes reagents, calibrators, and controls, which are typical components of an IVD assay system.
N/A
Intended Use / Indications for Use
Reagents
AxSYM HoloTC assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of holotranscobalamin (vitamin B12 bound to transcobalamin) in human serum and plasma on the AxSYM System. HoloTC is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.
Calibrators
The AxSYM HoloTC Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of holotranscobalmin (HoloTC) in human serum and plasma.
Controls
The AxSYM HoloTC Controls are for the use in quality control to monitor the accuracy and precision of the HoloTC assay when used for the quantitative determination of holotranscobalamin (HoloTC) in human serum and plasma on the AxSYM System.
For in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
CDD, JIT, JJX
Device Description
AxSYM HoloTC is based on Microparticle Enzyme Immunoassay (MEIA) technology. The AxSYM HoloTC reagents and sample are pipetted in the following sequence:
SAMPLING CENTER
- Sample and all AxSYM HoloTC reagents required for one test are pipetted by the . Sampling Probe into various wells of a Reaction Vessel (RV).
- . A reaction mixture is formed by combining diluted sample and microparticles coated with Anti-HoloTC monoclonal antibody in the sample well of the RV.
- . When human HoloTC antigen is present in the sample, it binds to the coated microparticles, forming antigen-antibody complexes on the microparticles.
- . The Anti-TC Antibody:Alkaline Phosphatase Conjugate is pipetted into a second well of the RV.
- The HoloTC Wash Buffer is pipetted into a third well of the RV.
- The Matrix Cell Wash is pipetted into a fourth well of the RV.
The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe.
PROCESSING CENTER
- . An aliquot of the reaction mixture, containing microparticles and bound antigenantibody complex, is transferred to the Matrix Cell. The microparticles bind irreversibly to the glass fiber matrix.
- The Matrix Cell is washed to remove materials not bound to the microparticles.
- The Anti-TC Antibody:Alkaline Phosphatase Conjugate is dispensed onto the Matrix Cell and it binds with the antigen-antibody complexes.
- The Matrix Cell is washed to remove conjugate not bound to the microparticles.
- The substrate, 4-Methylumbelliferyl Phosphate, is added to the Matrix Ccll. The alkaline phosphatase-labeled conjugate catalyzes the removal of a phosphate group from the substrate, yielding the fluorescent product, 4-Methylumbelliferone. This fluorescent product is measured by the MEIA optical assembly.
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
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 AxSYM HoloTC assay is substantially equivalent to the Axis-Shield HoloTC RIA radioassay in terms of precision, linearity, interferences and stability as demonstrated in non-clinical performance data in this 510(k) submission.
The AxSYM HoloTC assay demonstrated substantially equivalent performance to the Axis-Shield HoloTC RIA radioassay indicated by a mcthod comparison with a correlation coefficient of 0.90.
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.
K#030655
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
Ka62467
AxSYM® HoloTC 510(K) SUMMARY (Summary of Safety and Effectiveness)
NOV 2 2 2006
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of CFR.
Preparation Date: 15th August 2006
Dr Erica Conway Regulatory Affairs Manager Axis-Shield Diagnostics, Ltd. The Technology Park Dundee DD2 1XA, Scotland, UK
Device Name:
Reagents:
Classification Name: HoloTC test system Trade Name: AxSYM® HoloTC Immunoassay Common Name: Holotranscobalamin test Governing Regulation: 862.1810 Device Classification: Class II Classification Panel: Chemistry Product Code: CDD
Calibrators:
Classification Name: Calibrator, Secondary Trade Name: AxSYM® HoloTC Standard Calibrators Common Name: Calibrator Governing Regulation: 862.1150 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: JIT
Controls:
Classification Name: Single (specified) analyte controls (assayed and unassayed) Trade Name: AxSYM® HoloTC Control Common Name: Control Governing Regulation: 862.1660 Device Classification: Class I Product Code: JJX
Legally marketed device to which equivalency is claimed:
Axis-Shield HoloTC Radioimmunoassay (K#030655)
AxSYM IloloTC 510(k) Summary ADMIN 4.0 510(k) Summary 15th August 2006
Page 1 of 3
1
Intended Use of Device:
AxSYM HoloTC assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of holotranscobalamin (HoloTC) in human scrum and plasma on the AxSYM System. HoloTC is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.
The AxSYM HoloTC Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of holotranscobalmin (HoloTC) in human serum and plasma.
The AxSYM HoloTC Controls are for the use in quality control to monitor the accuracy and precision of the HoloTC assay when used for the quantitative determination of holotranscobalamin (HoloTC) in human serum and plasma on the AxSYM System.
Description of Device:
AxSYM HoloTC is based on Microparticle Enzyme Immunoassay (MEIA) technology. The AxSYM HoloTC reagents and sample are pipetted in the following sequence:
SAMPLING CENTER
- Sample and all AxSYM HoloTC reagents required for one test are pipetted by the . Sampling Probe into various wells of a Reaction Vessel (RV).
- . A reaction mixture is formed by combining diluted sample and microparticles coated with Anti-HoloTC monoclonal antibody in the sample well of the RV.
- . When human HoloTC antigen is present in the sample, it binds to the coated microparticles, forming antigen-antibody complexes on the microparticles.
- . The Anti-TC Antibody:Alkaline Phosphatase Conjugate is pipetted into a second well of the RV.
- 발 The HoloTC Wash Buffer is pipetted into a third well of the RV.
- 파 The Matrix Cell Wash is pipetted into a fourth well of the RV.
The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe.
PROCESSING CENTER
- . An aliquot of the reaction mixture, containing microparticles and bound antigenantibody complex, is transferred to the Matrix Cell. The microparticles bind irreversibly to the glass fiber matrix.
- B The Matrix Cell is washed to remove materials not bound to the microparticles.
- t The Anti-TC Antibody:Alkaline Phosphatase Conjugate is dispensed onto the Matrix Cell and it binds with the antigen-antibody complexes.
- " The Matrix Cell is washed to remove conjugate not bound to the microparticles.
- .. The substrate, 4-Methylumbelliferyl Phosphate, is added to the Matrix Ccll. The alkaline phosphatase-labeled conjugate catalyzes the removal of a phosphate group from the substrate, yielding the fluorescent product, 4-Methylumbelliferone. This fluorescent product is measured by the MEIA optical assembly.
AxSYM HoloTC 510(k) Summary ADMIN 4.0 510(k) Summary 15th August 2006
Page 2 of 3
2
Comparison of Technological Characteristics:
The AxSYM HoloTC assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of HoloTC in human scrum and plasma. The Axis-Shield HoloTC RIA is a competitive binding radioassay which uses a specific transcobalamin antibody to capture transcobalamin from the patient sample. The vitamin B12 bound to the captured transcobalamin is then measured by procedures commonly used in vitam to B12 assays.
Summary of Non-Clinical Performance:
The AxSYM HoloTC assay is substantially equivalent to the Axis-Shield HoloTC RIA radioassay in terms of precision, linearity, interferences and stability as demonstrated in non-clinical performance data in this 510(k) submission.
Summary of Clinical Performance:
The AxSYM HoloTC assay demonstrated substantially equivalent performance to the Axis-Shield HoloTC RIA radioassay indicated by a mcthod comparison with a correlation coefficient of 0.90.
Page 3 of 3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Erica Conway Regulatory Affairs Manager Axis-Shield Diagnostics, Ltd. The Technology Park Dundee DD2 1XA, Scotland, UK
NOV 2 2 2006
Re: K062467
Trade/Device Name: AxSYM® HoloTC REAGENTS, AxSYM® HoloTC STANDARD CALIBRATORS (A-F) and AxSYM® HoloTC CONTROLS (LOW and HIGH) Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: Class II Product Code: CDD, JIT, JJX Dated: August 21, 2006 Received: August 24, 2006
Dear Dr. Conway:
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 Foedd, Or o 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, into no 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 drivice 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 pratic requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
4
Page 2 –
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 Ilegally marketed predicate device results in a classification for your device and thus, perroits 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) 276-0484. Also, please nother 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 tolloffree mobile (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutt
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Product Classification - Indications for Use Statement ADMIN 5.0
510(k) Number (if known):
Device Name: AxSYM® HoloTC REAGENTS, AxSYM® HoloTC STANDARD CALIBRATORS (A-F) and AxSYM® HoloTC CONTROLS (LOW and HIGH)
Indications for Use:
Reagents
AxSYM HoloTC assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of holotranscobalamin (vitamin B12 bound to transcobalamin) in human serum and plasma on the AxSYM System. HoloTC is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.
Calibrators
The AxSYM HoloTC Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of holotranscobalmin (HoloTC) in human serum and plasma.
Controls
The AxSYM HoloTC Controls are for the use in quality control to monitor the accuracy and precision of the HoloTC assay when used for the quantitative determination of holotranscobalamin (HoloTC) in human serum and plasma on the AxSYM System.
For in vitro diagnostic use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
062467