(332 days)
No
The summary describes a standard immunoassay for measuring vitamin B12. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on traditional analytical and clinical validation metrics for an in-vitro diagnostic assay.
No.
Explanation: The device is described as an in-vitro diagnostic assay used for quantitative measurement in human serum or plasma to aid in the diagnosis and treatment of vitamin B12 deficiency. It is not an active therapeutic device that administers therapy or treatment.
Yes.
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device are used in the diagnosis and treatment of vitamin B12 deficiency."
No
The device is an in-vitro diagnostic assay that uses a competitive binding immunoassay with a specific monoclonal antibody and radioactive detection (37Co). This involves physical reagents and laboratory procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "in-vitro diagnostic assay for quantitative measurement of holotranscobalamin (vitamin B12 bound to transcobalamin) in human serum or plasma." It also states that the measurements are "used in the diagnosis and treatment of vitamin B12 deficiency." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Device Description: The description details a laboratory test performed on human samples (serum or plasma) to measure a specific analyte (holotranscobalamin). This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document includes various performance studies (Method Comparison, Reference Interval, Precision, Linearity, Interference, etc.) which are standard requirements for demonstrating the analytical and clinical performance of an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" (K993571; Bayer Advia Centaur VB12 assay) is common in regulatory submissions for IVDs, where a new device is compared to a legally marketed predicate device.
All these elements strongly indicate that the Axis-Shield HoloTC RIA is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Axis-Shield HoloTC RIA is an in-vitro diagnostic assay for quantitative mcasurement of holotranscobalamin (vitamin B12 bound to transcobalamin) in human serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of vitamin B12 deficiency. HoloTC RIA is calibrated with HoloTC Calibrators. HoloTC controls are assayed for the verification of the accuracy and precision of the HoloTC RIA.
Product codes (comma separated list FDA assigned to the subject device)
CDD; JIS; JJX
Device Description
The Axis-Shield HoloTC RIA is a competitive binding immunoassay in which a specific monoclonal antibody is used to capture transcobalamin from the patient sample. Thereafter the procedure is as commonly used in vitamin B12 assays. The cobalamin (vitamin B12) is released from the transcobalamin using dithiothreitol and sodium hydroxide. The released cobalamin (vitamin B12) then competes for a limited amount of intrinsic factor with added 'Co labelled vitamin B12.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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)
Method Comparison: The Axis-Shield HoloTC RIA was compared to the Bayer Advia Centaur VB12 assay (K993571) using 392 patient samples with vitamin B12 concentrations ranging from 114-821 pmol/L. Linear regression (least squares) yielded the following statistics: HoloTC pmol/L = 0.55 VB12-2 pmol/L r2 = 0.52.
Reference Interval: Based on a Finnish population of normal individuals (n=303, age 22-88 years) the 95% central reference interval was found to be 37-171 pmol/L. Analysis of covariance demonstrated that HoloTC levels depended on gender (but not age) in this reference population. The 90 % confidence intervals for the lower limit of the reference range are for the whole population, males and females 36-37 pmol/L, 37-39 pmol/L and 35-36 pmol/L, respectively.
External Evaluation: The Axis-Shield HoloTC RIA external laboratory performance was evaluated at two external study sites, UK and Denmark. Performance of the system was demonstrated by using three different levels of native and pooled serum samples in addition to kit controls Low and High. CV for the three serum samples were within the given acceptance criteria,
§ 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
510(K) Summary Axis-Shield HoloTC RIA
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
Statement of Intended Use
The Axis-Shield HoloTC RIA is an in-vitro diagnostic assay for quantitative mcasurement of holotranscobalamin (vitamin B12 bound to transcobalamin) in human serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of vitamin B12 deficiency. HoloTC RIA is calibrated with HoloTC Calibrators. HoloTC controls are assayed for the verification of the accuracy and precision of the HoloTC RIA.
Summary of Technological Characteristics
The Axis-Shield HoloTC RIA is a competitive binding immunoassay in which a specific monoclonal antibody is used to capture transcobalamin from the patient sample. Thereafter the procedure is as commonly used in vitamin B12 assays. The cobalamin (vitamin B12) is released from the transcobalamin using dithiothreitol and sodium hydroxide. The released cobalamin (vitamin B12) then competes for a limited amount of intrinsic factor with added 'Co labelled vitamin B12. The Axis-Shield HoloTC RIA differs from the predicate device in two main aspects:
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- The use of a transcobalamin specific antibody, this allows the quantitation of only the cobalamin bound to the protein transcobalamin as opposed to measurement of cobalamin bound to all proteins in the predicate device and
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- The detection signal is radioactivity (37Co) as opposed to chemiluminescence in the predicate device.
Method Comparison
The Axis-Shield HoloTC RIA was compared to the Bayer Advia Centaur VB12 assay (K993571) using 392 patient samples with vitamin B12 concentrations ranging from 114-821 pmol/L.
Linear regression (least squares) vielded the following statistics:
\HoloTC pmol/L = 0.55\VB12-2 pmol/L r2 = 0.52
Reference Interval
Based on a Finnish population of normal individuals (n=303, age 22-88 years) the 95% central reference interval was found to be 37-171 pmol/L.
Analysis of covariance demonstrated that HoloTC levels depended on gender (but not age) in this reference population. The 90 % confidence intervals for the lower limit of the reference range are for the whole population, males and females 36-37 pmol/L, 37-39 pmol/L and 35-36 pmol/L, respectively.
1
External Evaluation
The Axis-Shield HoloTC RIA external laboratory performance was evaluated at two external study sites, UK and Denmark. Performance of the system was demonstrated by using three different levels of native and pooled serum samples in addition to kit controls Low and High. CV for the three serum samples were within the given acceptance criteria,