(48 days)
BioRad Quantaphase II B12/Folate Radioassay
No
The device description details a standard immunoassay method based on chemical reactions and optical detection, with results determined via a calibration curve. There is no mention of AI or ML in the description, performance studies, or key metrics.
No
The device measures vitamin B12 levels for diagnosis and treatment of anemias, but it does not directly treat or restore health.
Yes
The "Intended Use / Indications for Use" states that "Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption," which clearly indicates its use as a diagnostic device.
No
The device description details a complex chemical assay process involving reagents, incubations, microparticles, and a chemiluminescent detection system with a photomultiplier. This clearly indicates a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to measure vitamin B12 in serum, plasma, and urine" and that these measurements "are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption." This clearly indicates that the device is used to examine specimens derived from the human body for the purpose of providing information for the diagnosis and treatment of a disease.
- Device Description: The description details a laboratory-based assay process involving chemical reactions and measurement of a substance (vitamin B12) in biological samples (serum, plasma, urine). This is characteristic of an in vitro diagnostic device.
- Performance Studies: The performance studies compare the device to a predicate device (BioRad Quantaphase II B12/Folate Radioassay) which is also an IVD. The metrics evaluated (Precision, Lower Detection Limit, Linearity, Method Comparison) are standard for evaluating the performance of IVD assays.
Based on the provided information, the device meets the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Assay for the in vitro quantitative determination of Vitamin B12 in human serum and plasma.
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.
Product codes
CDD
Device Description
Competition principle. Total duration of assay: 18 minutes, 37*C. Competition principic. Total adalabating the sample (15 mL) with the incubation (9 immutes). By metreatment 2 (15 mL), bound Vitamin B12 is liberated into the serum.
2nd incubation (9 minutes): By incubating the pretreated sample with the •2nd incubation (9 innutes): Dy most, and immunocomplex is formed, the ruthenylated" * " intrilisic Tactor (70 this), " = " = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = · 3rd incubation (9 minutes): After addition of of streptaviding of a streptaviding of the still, •3rd incubation (9 mL) and Vitamin B12 labeled with biotin (60 mL), the still-microparticles (30 mL) and Vitalini Dr.2 recorder become occupied, with the vacant sites of the ruthenylated Intrinst For and B12 biotin complex.
formation of an ruthenylated Intrinsic Factor-Viraming of biotin formation of an rutherrylated markisto i actor-phase via interaction of biotin.
The entire complex becomes bound to the solid phase via interaction of biotin. and streptavidin.
The reaction mixture is aspirated into the measuring cell where the · I he reaction inixture is aspirated onto the surface of the electrode. microparticles are then removed with Procell. Application of a voltage Unbound substances are then removed was a secure in which is measured to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).
Results are determined via a calibration curve which is instrument-· Results are 'delemined ' via- a 'culturation and a master curve provided via the reagent bar code.
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)
Precision:
Elecsys Vitamin B12
Modified NCCLS (pg/ml):
Pool N=60
Pool 1 Mean: 203.27, Within run SD: 14.11, %CV: 6.94, Total SD: 15.41, %CV: 7.58
Pool 2 Mean: 481.02, Within run SD: 20.38, %CV: 4.24, Total SD: 21.08, %CV: 4.38
Pool 3 Mean: 1499.36, Within run SD: 41.23, %CV: 2.75, Total SD: 47.78, %CV: 3.19
Level N=60
Level 1 Mean: 1119.49, Within run: 31.28, %CV: 2.79, Total: 36.20, %CV: 3.23
Level 2 Mean: 471.30, Within run: 25.84, %CV: 5.48, Total: 26.77, %CV: 5.68
BioRad Quantaphase II B12/Folate Radioassay
Within-Run and Total Precision (pg/ml):
Pool N=40
I Mean: 127, Within run SD: 8.9, %CV: 4.10, Total SD: 8.6, %CV: 6.8
II Mean: 273, Within run SD: 15.7, %CV: 4.1, Total SD: 29.3, %CV: 6.8
III Mean: 622, Within run SD: 51.7, %CV: 5.9, Total SD: 36.2, %CV: 4.5
IV Mean: 1325, Within run SD: 52.8, %CV: 4.0, Total SD: 75.3, %CV: 5.7
Lower Detection Limit:
Elecsys Vitamin B12: 30 pg/ml
BioRad Quantaphase II B12/Folate Radioassay: 20 pg/ml
Linearity:
Elecsys Vitamin B12: 30 - 2000 pg/ml
BioRad Quantaphase II B12/Folate Radioassay: 20 - 2000 pg/ml
Method Comparison:
Elecsys Vitamin B12 vs BioRad Quantaphase II B12/Folate Radioassay
Least Squares: y = 1.02X + 6.5, r=0.9751, N=346
Passing Bablock: y=1.06X - 9.5, r=0.9751, N=346
BioRad Quantaphase II B12/Folate Radioassay vs Commercially available RIA
y = 1.01x + 44, r=0.933, N=84
Interfering substances (no interference at):
Elecsys Vitamin B12:
Bilirubin: 80 mg/dL
Hemoglobin: 1800 mg/dL
Lipemia: 2500 mg/dL
Rheumatoid Factor: 500 IU/mL
Dysproteinemia: 8.8 g/dL
Biotin: 50 pg/ml
BioRad Quantaphase II B12/Folate Radioassay:
Bilirubin: 20 mg/dL unconjugated, 20 mg/dL conjugated
Hemoglobin: 500 mg/dL
Lipemia: 3000 mg/dL
Reference Range Vitamin B12, pg/ml:
Elecsys Vitamin B12: Normal: 243 - 894, Indeterminant: 175 - 244, Deficient:
§ 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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits. The digits appear to be '4973702'. The numbers are written in black ink on a white background. The handwriting is somewhat stylized, with some numbers appearing more rounded than others.
NOV 1 3 1997
| 510(k) Summary | |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following information |
| provides sufficient detail to understand the basis for a determination of | |
| substantial equivalence. | |
| 1. | |
| Submitter | |
| name, | |
| address, | |
| contact | Boehringer Mannheim Corporation |
| 4300 Hacienda Drive | |
| Pleasanton, CA 94588-2722 | |
| (510) 730 - 8413 | |
| Contact Person: Yvette Lloyd | |
| Date Prepared: September 24, 1997 | |
| 2. Device name | Proprietary name: Elecsys Vitamin B12 Assay |
| Common name: Electrochemiluminescent immunoassay for the determination | |
| of Vitamin B12. | |
| Classification name: System, Test, Vitamin B12 | |
| 3. Predicate | |
| device | The Boehringer Mannheim Elecsys Vitamin B12 is substantially equivalent to |
| other products in commercial distribution intended for similar use. Most | |
| notably it is substantially equivalent to the currently marketed BioRad | |
| Quantaphase II B12/Folate Assay (K935286). |
1
10(k) Summary, Continued
l
- Device Description Competition principle. Total duration of assay: 18 minutes, 37*C. Competition principic. Total adalabating the sample (15 mL) with the •] * incubation (9 immutes). By metreatment 2 (15 mL), bound Vitamin B12 is liberated into the serum.
·2nd incubation (9 minutes): By incubating the pretreated sample with the •2nd incubation (9 innutes): Dy most, and immunocomplex is formed, the ruthenylated" * " intrilisic Tactor (70 this), " = " = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = · 3rd incubation (9 minutes): After addition of of streptaviding of a streptaviding of the still, •3rd incubation (9 mL) and Vitamin B12 labeled with biotin (60 mL), the still-
microparticles (30 mL) and Vitalini Dr.2 recorder become occupied, with the vacant sites of the ruthenylated Intrinst For and B12 biotin complex.
formation of an ruthenylated Intrinsic Factor-Viraming of biotin formation of an rutherrylated markisto i actor-phase via interaction of biotin.
The entire complex becomes bound to the solid phase via interaction of biotin. and streptavidin.
·The reaction mixture is aspirated into the measuring cell where the · I he reaction inixture is aspirated onto the surface of the electrode. microparticles are then removed with Procell. Application of a voltage Unbound substances are then removed was a secure in which is measured
to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).
·Results are determined via a calibration curve which is instrument-· Results are 'delemined ' via- a 'culturation and a master curve provided via the reagent bar code.
**Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)**3)
2
| 510(k) Summary, Continued | |
|---|---|
| 5. | |
| Intended use | Assay for the in vitro quantitative determination of Vitamin B12 in human serum and plasma. |
| 6. | |
| Comparison to predicate device | The Boehringer Mannheim Elecsys Vitamin B12 Assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed BioRad Quantaphase II B12/Folate Assay (K935286). |
| The following table compares the Elecsys Vitamin B12 Assay with the predicate device, BioRad Quantaphase II B12/Folate Assay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device is provided in attachment 6. | |
| Similarities: | |
| Intended Use: Assay for the in vitro quantitative determination of Vitamin B12Sample type: Serum and plasmaAssay range: 0- 2000 pg/mLSame binding protein: Porcine Intrinsic Factor |
3
10(k) Summary, Continued
1 1 1 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Comparison to predicate device cont.
Differences:
| Feature | Elecsys
Vitamin B12 | Biorad Quantaphase II
B12/Folate radioassay |
|----------------------------|--------------------------|------------------------------------------------|
| Reaction test
principle | Electrochemiluminescence | Radiobinding assay using
57Co |
| Instrument
required | Elecsys 2010 | Gamma Counter |
Performance Characteristics:
| Feature | Elecsys Vitamin B12
Modified NCCLS (pg/ml): | BioRad Quantaphase II
B12/Folate Radioassay
Within-Run and Total Precision
(pg/ml): |
|--------------------|------------------------------------------------|----------------------------------------------------------------------------------------------|
| Precision
Level | Pool 1 | I |
| | Pool 2 | II |
| | Pool 3 | III |
| | | IV |
| N | 60 | 40 |
| | 60 | 40 |
| | 60 | 40 |
| | | 40 |
| Mean | 203.27 | 127 |
| | 481.02 | 273 |
| | 1499.36 | 622 |
| | | 1325 |
| Within run SD | 14.11 | 8.9 |
| | 20.38 | 15.7 |
| | 41.23 | 51.7 |
| | | 52.8 |
| %CV | 6.94 | 4.10 |
| | 4.24 | 4.1 |
| | 2.75 | 5.9 |
| | | 4.0 |
| Mean | 203.27 | 127 |
| | 481.02 | 429 |
| | 1499.36 | 807 |
| | | 1314 |
| Total SD | 15.41 | 8.6 |
| | 21.08 | 29.3 |
| | 47.78 | 36.2 |
| | | 75.3 |
| %CV | 7.58 | 6.8 |
| | 4.38 | 6.8 |
| | 3.19 | 4.5 |
| | | 5.7 |
| Level | Level 1 | |
| | Level 2 | |
| N | 60 | |
| | 60 | |
| Mean | 1119.49 | |
| | 471.30 | |
| Within run | 31.28 | |
| | 25.84 | |
| %CV | 2.79 | |
| | 5.48 | |
| Mean | 1119.49 | |
| | 471.30 | |
| Total | 36.20 | |
| | 26.77 | |
| %CV | 3.23 | |
| | 5.68 | |
4
10(k) Summary, Continued
Image /page/4/Picture/1 description: The image shows the logo for Boehringer Mannheim Corporation. The text is stacked on top of each other in a bold, sans-serif font. The words are all capitalized and in black.
Performance Characteristics:
- Comparison
to predicate
device, (cont.)
Performance Characteristics:
| Feature | Elecsys Vitamin B12 | BioRad Quantaphase II
B12/Folate Radioassay |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Lower
Detection
Limit | 30 pg/ml | 20 pg/ml |
| Linearity | 30 - 2000 pg/ml | 20 - 2000 pg/ml |
| Method
Comparison | Vs BioRad Quantaphase II
B12/Folate Radioassay
Least Squares
$y =1.02X + 6.5$
$r=0.9751$
$N=346$
Passing Bablock:
$y=1.06X - 9.5$
$r=0.9751$
$N=346$ | Vs Commercially available
radioimmunoassay
$y =1.01x + 44$
$r=0.933$
$N=84$ |
5
10(k) Summary, Continued RPORATIC
o.
Comparison
to predicate
device, (cont.)
i
Performance Characteristics:
| Feature | Elecsys Vitamin B12 | BioRad Quantaphase II
B12/Folate Radioassay |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Interfering
substances | No interference at:
(within 30 pg/ml at
Vitamin B12 level 300
pg/ml.) | No interference at: |
| Bilirubin | 80 mg/dL | 20 mg/dL unconjugated
20 mg/dL conjugated |
| Hemoglobin | 1800 mg/dL | 500 mg/dL |
| Lipemia | 2500 mg/dL | 3000 mg/dL |
| Rheumatoid Factor | 500 IU/mL | N/A |
| Dysproteinemia | 8.8 g/dL | N/A |
| Biotin | 50 pg/ml | N/A |
| Reference
Range
Vitamin B12,
pg/ml | Normal: 243 - 894
Indeterminant:
175 - 244
Deficient: