(90 days)
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No
The description focuses on a quantitative assay using standard laboratory techniques and does not mention any AI/ML components or algorithms.
No
This device is an in vitro diagnostic assay used for the quantitative determination of vitamin B12, not for treating or diagnosing a disease.
Yes
The device is described as an "assay for the quantitative determination of vitamin B12 in human serum or plasma," which indicates its purpose is to measure a biological substance to aid in diagnosis.
No
The device description clearly states it is a "microparticle enzyme intrinsic factor assay," which is a laboratory test involving physical reagents and equipment, not solely software.
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 vitamin B12 in human serum or plasma." This involves testing biological samples (serum or plasma) outside of the body to provide information about a person's health status (vitamin B12 levels).
- Device Description: The description further clarifies that it's a "microparticle enzyme intrinsic factor assay," which is a laboratory technique used to measure substances in biological samples.
- Performance Studies: The performance studies describe a correlation analysis using "specimens," which are biological samples.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
AxSYM B12 is a microparticle enzyme intrinsic factor assay for the quantitative determination of vitamin B12 in human serum or plasma.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
AxSYM B12 is a microparticle enzyme intrinsic factor assay for the quantitative determination of vitamin B12 in human serum or plasma. AxSYM B12 is calibrated with Abbott B12 calibrators. Abbott B12 controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.
Mentions image processing
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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)
A correlation analysis between these two assays, using 337 specimens, yielded a correlation coefficient of 0.975, slope of 1.00, standard error of y estimate of 67.281, and y-intercept of -12.371 pg/mL. Both assays have a dynamic range of 60 to 2,000 pg/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient of 0.975, slope of 1.00, standard error of y estimate of 67.281, y-intercept of -12.371 pg/mL.
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.
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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.
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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).
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§ 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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510(k) Summary Abbott AxSYM® B12
MAR 2 4 1997
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The following information as presented in the Premarket Notification for AxSYM® B12 constitutes data supporting a substantially equivalent determination.
AxSYM B12 is a microparticle enzyme intrinsic factor assay for the quantitative determination of vitamin B12 in human serum or plasma. AxSYM B12 is calibrated with Abbott B12 calibrators. Abbott B12 controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.
Substantial equivalence has been demonstrated between the Abbott AxSYM B12 assay and the Abbott IMx® B12 assay. The intended use of both assays is for the quantitative determination of vitamin B12. AxSYM B12 can be performed with human serum or plasma (tripotassium EDTA and potassium oxalate). However, IMx B12 can be performed on human serum and plasma (EDTA only). A correlation analysis between these two assays, using 337 specimens, yielded a correlation coefficient of 0.975, slope of 1.00, standard error of y estimate of 67.281, and y-intercept of -12.371 pg/mL. Both assays have a dynamic range of 60 to 2,000 pg/mL.
In conclusion, these data demonstrate that Abbott AxSYM B12 is safe and effective, and is substantially equivalent to Abbott IMx B12.
Prepared and Submitted December 23, 1996 by:
Laura Granitz (847)-938-0092 Senior Regulatory Specialist Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537
AxSYM B12 510(k) December 1996 aB12510k