(78 days)
AxSYM® B12 Assay
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No
The summary describes a standard laboratory assay (Chemiluminescent Microparticle Intrinsic Factor assay) for measuring B12 levels. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies described are standard statistical analyses for comparing assay results.
No.
The device is an in vitro diagnostic assay used for the quantitative determination of B12, which aids in the diagnosis and treatment of anemias. It does not directly treat or cure a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption."
No
The device description clearly indicates it is a "Chemiluminescent Microparticle Intrinsic Factor assay" which is a laboratory test involving physical reagents and a system (ARCHITECT™ i System) for analysis, 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 measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. This is a key characteristic of an IVD, as it's used to provide information for diagnostic purposes.
- Device Description: The description details a "Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum and plasma." This describes a test performed on biological samples (serum and plasma) outside of the body, which is the definition of "in vitro."
- Sample Type: The device analyzes human serum and plasma, which are biological specimens.
- Purpose: The purpose is the "quantitative determination of B12," which is a measurement used to assess a patient's health status and aid in diagnosis.
All of these points align with the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Abbott ARCHITECT™ B12 assay is a Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of B12 in human serum and plasma on the Abbott ARCHITECT™ i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
Product codes
LIG
Device Description
The ARCHITECT B12 assay is a Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum and plasma (tripotassium EDTA). The ARCHITECT B12 assay is calibrated with Abbott ARCHITECT B12 Calibrators. Abbott B12 Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i 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 least squares linear regression analysis between these two assays, using 544 serum specimens, over the range of 60 to 2000 pg/mL, yielded a correlation coefficient of 0.956, a slope of 0.96 (95% Confidence Interval [CI] of 0.93 to 0.98), and an intercept of -27 pg/mL (95% CI of -42 to -12). Passing-Bablok linear regression analysis between these two assays gave a correlation coefficient of 0.956, a slope of 0.91 (95% CI of 0.89 to 0.93), and an intercept of -7 pg/mL (95% CI of -18 to 2).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient of 0.956, a slope of 0.96 (95% Confidence Interval [CI] of 0.93 to 0.98), and an intercept of -27 pg/mL (95% CI of -42 to -12)
Predicate Device(s)
AxSYM® B12 Assay
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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3 33 FEB
510(k) Summary
Abbott ARCHITECT™ B12
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The following information as presented in the Premarket Notification [510(k)] for Abbott ARCHITECT™ B12 constitutes data supporting a substantially equivalent determination.
The ARCHITECT B12 assay is a Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum and plasma (tripotassium EDTA). The ARCHITECT B12 assay is calibrated with Abbott ARCHITECT B12 Calibrators. Abbott B12 Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i System.
Substantial equivalence has been demonstrated between the ARCHITECT B12 assay and the AxSYM® B12 Assay. The intended use of both assays is for the quantitative determination of vitamin B12 in human serum and plasma. A least squares linear regression analysis between these two assays, using 544 serum specimens, over the range of 60 to 2000 pg/mL, vielded a correlation coefficient of 0.956, a slope of 0.96 (95% Confidence Interval [CI] of 0.93 to 0.98), and an intercept of -27 pg/mL (95% CI of -42 to -12). Passing-Bablok linear regression analysis between these two assays gave a correlation coefficient of 0.956, a slope of 0.91 (95% CI of 0.89 to 0.93), and an intercept of -7 pg/mL (95% CI of -18 to 2).
In conclusion, these data demonstrate that the ARCHITECT B12 assay is as safe and effective as, and is substantially equivalent to, the AxSYM® B12 Assay.
Prepared and Submitted November 16, 1998 by: Laura Granitz Senior Regulatory Specialist 1-847-938-0092
Abbott Laboratories ADD Regulatory Affairs 200 Abbott Park Road Abbott Park, IL 60064-3537
ARCHITECT B12 510(k) November, 1998 B12 510k.doc
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Public Health Service
Image /page/1/Picture/2 description: The image shows a black and white logo. The logo is the symbol of the U.S. Department of Health and Human Services (HHS). The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, and the word "DEPARTMENT" is partially visible on the left side of the image.
3 1099 FEB
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Laura L. Granitz Senior Regulatory Specialist ADD Regulatory Affairs Abbott Laboratories Diagnostic Division Dept. 9V6 Building AP31 200 Abbott Park Road Abbott Park, Illinois 60064
Re: K984108
Trade Name: Abbott ARCHITECT™ B12 Regulatory Class: II Product Code: LIG Dated: November 16, 1998 Received: November 17, 1998
Dear Ms. Granitz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 Food, Drug, and Cosmetic Act (Act). 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, listing 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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984108 510(k) Number (if known):_ Device Name: Abbott ARCHITECT™ B12
Indications For Use:
The Abbott ARCHITECT™ B12 assay is a Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of B12 in human serum and plasma on the Abbott ARCHITECT™ i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K984108
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use U
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109) (Optional Format 1-2-96)