(262 days)
Not Found
No
The device description and performance studies focus on standard immunoassay components and analytical performance metrics, with no mention of AI or ML.
No
The device is an assay for determining HoloTC levels, which aids in the diagnosis and treatment of vitamin B12 deficiency. It does not actively treat a condition.
Yes
The device is described as an "aid in the diagnosis and treatment of vitamin B12 deficiency," which directly indicates its purpose as a diagnostic tool.
No
The device description explicitly lists multiple physical components, including a microtitre plate, calibrators, controls, solutions, and buffers, indicating it is a hardware-based assay kit, not software only.
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 (HoloTC) in human serum" and is used "as an aid in the diagnosis and treatment of vitamin B12 deficiency." This clearly indicates it's a test performed on a biological sample (human serum) to provide information for medical diagnosis and treatment.
- Device Description: The description details the components of an immunoassay kit, which is a common type of IVD used for measuring substances in biological fluids.
- Performance Studies: The document describes non-clinical and clinical performance studies conducted to evaluate the assay's performance using human serum samples. This is a standard requirement for demonstrating the safety and effectiveness of an IVD.
- Predicate Device: The mention of a predicate device (ARCHITECT Active-B12 (Holotranscobalamin)) with a K number (K112443) indicates that this device is being compared to a previously cleared IVD, which is part of the regulatory process for IVDs.
All these factors strongly point to the Axis-Shield Active-B12 (Holotranscobalamin) assay being an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC) in human serum. HoloTC (vitamin B12 bound to transcobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.
For in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
CDD
Device Description
The Axis-Shield Active-B12 (Holotranscobalamin) device contains the following components: a microtitre plate with 8 x 12-well breakapart strips coated with a anti-holotranscobalamin murine monoclonal antibody, in a resealable foil pack with desiccant; ready-to-use calibrators, low and high controls (phosphate buffer containing protein (bovine) stabiliser and sodium azide preservative with or without recombinant HoloTC); ready-to-use pre-treatment solution; murine anti-human transcobalamin alkaline phosphatase conjugate; para-NitroPhenyl Phosphate (pNPP) substrate; wash buffer (8x); ready-to-use stop solution.
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
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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)
Dilution Linearity
The Axis-Shield Active-B12 (Holotranscobalamin) EIA demonstrated linearity across the measuring range of the assay from 5.3 to 156.0 pmol/L.
Reportable Range
The Axis-Shield Active-B12 (Holotranscobalamin) ElA reportable range is 10 to 128 pmol/L.
Analytical limits at low levels
a representative study, the limit of blank of the Axis-Shield ln Active-B12 (Holotranscobalamin) ElA was 4.9 pmol/L, the limit of detection was 8.1 pmol/L and the limit of quantification was 8.3 pmol/L.
High Dose Hook
No high dose hook effect was detected up to a concentration of 2236pmol/L Holotranscobalamin.
Cross-reactivity
The Axis-Shield Active-B12 (Holotranscobalamin) EIA is designed to have a maximum deviation in holotranscobalamin concentration of ≤10% in the presence of 500 pmol/L apotranscobalamin or 5000 pmol/L haptocorrin. The maximum deviation in holotranscobalamin concentration ranged from -5% to 1%.
Interference
The Axis-Shield Active-B12 (Holotranscobalamin) EIA is designed to have a maximum deviation in holotranscobalamin concentration of ≤10% in the presence of potentially interfering compounds. The maximum deviation in holotranscobalamin concentration ranged from -10% to 8% for the potentially interfering compounds presented.
Precision-
8 human serum samples were assayed using 3 lots of reagents. Samples were assayed by 2 operators in replicates of 8, once a day for 5 days (total n=80). Data from this study are summarised in the following table:
| Sample | n | Lot | Operator | Mean (pmol/l) | Intra-assay %CV | Total %CV |
|---|---|---|---|---|---|---|
| 1 A | 80 | 1 | 1 | 17.8 | 7.5% | 8.2% |
| 1 | 2 | 17.5 | 3.1% | 9.3% | ||
| 2 | 1 | 20.1 | 6.0% | 6.6% | ||
| 2 | 2 | 20.3 | 6.9% | 9.2% | ||
| 3 | 1 | 19.1 | 5.5% | 8.0% | ||
| 3 | 2 | 18.9 | 8.5% | 11.0% | ||
| 2 A | 80 | 1 | 1 | 21.8 | 5.5% | 9.9% |
| 1 | 2 | 21.8 | 3.9% | 7.5% | ||
| 2 | 1 | 22.6 | 5.6% | 8.7% | ||
| 2 | 2 | 23.5 | 9.0% | 10.3% | ||
| 3 | 1 | 23.9 | 7.0% | 10.2% | ||
| 3 | 2 | 23.2 | 5.8% | 8.9% | ||
| 3 A | 80 | 1 | 1 | 28.8 | 3.8% | 7.8% |
| 1 | 2 | 30.7 | 4.3% | 9.6% | ||
| 2 | 1 | 31.0 | 6.8% | 8.0% | ||
| 2 | 2 | 31.4 | 4.3% | 6.1% | ||
| 3 | 1 | 31.5 | 4.5% | 6.4% | ||
| 3 | 2 | 32.2 | 4.0% | 9.2% | ||
| 4 A | 80 | 1 | 1 | 49.3 | 3.9% | 7.4% |
| 1 | 2 | 52.6 | 4.1% | 6.7% | ||
| 2 | 1 | 50.8 | 5.6% | 10.0% | ||
| 2 | 2 | 51.7 | 4.7% | 5.9% | ||
| 3 | 1 | 52.6 | 4.6% | 4.8% | ||
| 3 | 2 | 55.0 | 5.5% | 6.1% | ||
| 5 A | 80 | 1 | 1 | 68.4 | 4.0% | 7.6% |
| 1 | 2 | 73.2 | 3.7% | 7.5% | ||
| 2 | 1 | 74.8 | 4.3% | 8.2% | ||
| 2 | 2 | 75.9 | 4.6% | 6.4% | ||
| 3 | 1 | 75.1 | 4.4% | 7.9% | ||
| 3 | 2 | 76.3 | 4.9% | 6.2% | ||
| 7 A | 80 | 1 | 1 | 115.9 | 4.2% | 5.9% |
| 1 | 2 | 121.1 | 3.6% | 7.0% | ||
| 2 | 1 | 123.2 | 4.3% | 10.2% | ||
| 2 | 2 | 124.0 | 4.2% | 6.4% | ||
| 3 | 1 | 127.0 | 4.8% | 10.1% | ||
| 3 | 2 | 129.5 | 3.2% | 5.6% | ||
| Low Control | 80 | 1 | 1 | 23.7 | 9.4% | 10.9% |
| 1 | 2 | 23.8 | 5.1% | 11.5% | ||
| 2 | 1 | 20.0 | 6.0% | 7.5% | ||
| 2 | 2 | 18.6 | 5.8% | 8.5% | ||
| 3 | 1 | 20.3 | 8.3% | 9.7% | ||
| 3 | 2 | 20.1 | 8.3% | 10.0% | ||
| High Control | 80 | 1 | 1 | 61.2 | 6.3% | 6.4% |
| 1 | 2 | 58.8 | 4.5% | 8.9% | ||
| 2 | 1 | 50.3 | 6.3% | 8.1% | ||
| 2 | 2 | 50.2 | 5.9% | 8.4% | ||
| 3 | 1 | 52.2 | 7.7% | 9.2% | ||
| 3 | 2 | 50.8 | 5.8% | 8.5% |
Matrix Comparison
Specimens collected in serum (clot) and serum separator (SST) tubes are compatible in the Axis-Shield Active-B12 (Holotranscobalamin) assay shown by a correlation study.
Number of Specimens (n): > 36
Slope of regression line (Passing-Bablok regression): > 0.97
Correlation coefficient (r) (Pearson): 0.98
Overall percent bias (%):
§ 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
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: K121946
Owners Name:
Axis-Shield Diagnostics Ltd. The Technology Park, Dundee DD2 1XA, UK Tel. +44(0) 1382 422 000 Fax. +44(0) 1382 422 088
Name of contact person:
Dr Simon Richards QA/RA Director Axis-Shield Diagnostics Ltd.
Date summary prepared:
March 8th, 2013
Device Name: Axis-Shield Active-B12 (Holotranscobalamin)
Classification Name: Vitamin B12 test system Trade Name: Axis-Shield Active-B12 (Holotranscobalamin) Common Name: Holotranscobalamin test Governing Regulation: 862.1810 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: CDD
Legally marketed device to which equivalency is claimed: ARCHITECT Active-B12 (Holotranscobalamin) (K112443)
Axis-Shield Active-B12 (Holotranscobalamin), K121946 510(k) Summary Final
ਾ ਪ
1
Intended Use of Device:
The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC) in human serum. HoloTC (vitamin B12 bound to transcobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.
Description of Device:
The Axis-Shield Active-B12 (Holotranscobalamin) device contains the following components: a microtitre plate with 8 x 12-well breakapart strips coated with a anti-holotranscobalamin murine monoclonal antibody, in a resealable foil pack with desiccant; ready-to-use calibrators, low and high controls (phosphate buffer containing protein (bovine) stabiliser and sodium azide preservative with or without recombinant HoloTC); ready-to-use pre-treatment solution; murine anti-human transcobalamin alkaline phosphatase conjugate; para-NitroPhenyl Phosphate (pNPP) substrate; wash buffer (8x); ready-to-use stop solution.
Principle of the Assay:
The microtitre wells are coated with a highly specific monoclonal antibody for Active-B12 (Holotranscobalamin). During the first incubation holotranscobalamin in serum specifically binds to the antibody-coated surface. In the second incubation the Conjugate binds to any captured holotranscobalamin. The wells are then washed to remove unbound components. Bound holotranscobalamin is detected by incubation with the Substrate. Addition of Stop Solution terminates the reaction, resulting in a coloured end-product. The concentration of holotranscobalamin in pmol/L is directly related to the colour generated and can be estimated by interpolation from a dose-response curve based on Calibrators.
Comparison of Technological Characteristics:
Axis-Shield Active-B12 (Holotranscobalamin) and ARCHITECT Active-B12 (Holotranscobalamin) are both immunoassays for the quantitative determination of Holotranscobalamin (HoloTC) in human serum.
The predicate device is an automated Chemiluminescent mircoparticle immunoassay (CMIA) whereas the submission device is a manual enzyme-linked immunosorbent assays also demonstrated substantial equivalence in terms antibodies employed and units of measure.
2
| Comparison of the subject device with the predicate device: | ||||||||
|---|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | -- | ------------------------------------------------------------- | -- |
| Submission device | Predicate device | |
|---|---|---|
| Parameter | Axis-Shield Active-B12 (Holotranscobalamin) | |
| Intended use | The Axis-Shield Active-B12 | |
| (Holotranscobalamin) assay is an enzyme- | ||
| immunoassay (EIA) for the quantitative | ||
| determination of holotranscobalamin | ||
| (HoloTC) in human serum. HoloTC (vitamin | ||
| B12 bound to transcobalamin) is used as an | ||
| aid in the diagnosis and treatment of vitamin | ||
| B12 deficiency. | Chemiluminescent microparticle | |
| immunoassay (CMIA) 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. | ||
| Antibodies employed | Murine monoclonal antibody 3C4 | |
| Murine monoclonal antibody 3-11 | Murine monoclonal antibody 3C4 | |
| Murine monoclonal antibody 3-11 | ||
| Substrate / Signal | ||
| Generation | Alkaline phosphatase | Acridinium Tracer |
| Specimen type | Serum and Serum Separator | Serum and Serum Separator |
| Storage conditions | 2-8°C. | 2-8°C. |
| Calibration | 6-point calibration curve. | |
| Linear regression curve-fit | 6-point calibration curve. | |
| 4PLC Y-weighted | ||
| Measuring Interval | 10 to 128 pmol/L | 5.0 to 128.0 pmol/L |
| Detection Limits | Limit of Quantitation of 8.3 pmol/L | Limit of Quantitation of ≤ 5.0 pmol/L |
| Linearity on Dilution | LOQ to Calibrator F | LOQ to Calibrator F |
| Expected Values in | ||
| Asymptomatic | ||
| Population | The mean Holotranscobalamin concentration | |
| (derived from log-transformed data to | ||
| normalize the population) was 72 pmol/L | ||
| with a range from 15 to 147 pmol/L. | ||
| The central 95% of the population defined | ||
| the expected range of | ||
| 21 to 123pmol/L (n= 135) | The mean Holotranscobalamin | |
| concentration (derived from log- | ||
| transformed data to normalize the | ||
| population) was 71.9pmol/L with a range | ||
| from 20.6 to 196.7 pmol/L. | ||
| The central 95% of the population defined | ||
| the expected range of | ||
| 25.1 to 165.0 pmol/L (n=181) | ||
| Cross-reactivity | No detectable carryover with; | |
| Apotranscobalamin at 500 pmol/L | ||
| Haptocorrin at 5000 pmol/L | No detectable carryover with; | |
| Apotranscobalamin at 500 pmol/L | ||
| Haptocorrin at 5000 pmol/L | ||
| Interference | ≤ 10% with; | |
| Bilirubin at 0.3 mg/mL | ||
| Haemoglobin at 5 mg/mL | ||
| Triglycerides at 30 mg/mL | ||
| Rheumatoid Factor at 75 IU/mL | ||
| Total protein at 90 mg/mL | ≤ 10% with; | |
| Bilirubin at 20 mg/dL | ||
| Haemoglobin at 200 mg/dL | ||
| Triglycerides at 850 mg/dL | ||
| Rheumatoid Factor at 70 IU/mL | ||
| Total protein at 10 g/dL | ||
| Imprecision | Total %CV ≤ 12% | |
| Within-run %CV ≤ 9% | Total %CV ≤ 5.8% | |
| Within-run %CV 36 | ||
| Slope of regression line (Passing-Bablok regression) | > 0.97 | |
| Correlation coefficient (r) (Pearson) | 0.98 | |
| Overall percent bias (%) |