(75 days)
The AxSYM B12 reagent is a microparticle enzyme intrinsic factor assay for the quantitative determination of vitamin B12 in human serum or plasma on the AxSYM System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
The AxSYM B12 Specimen Diluent is used for manually diluting specimens for testing using the AxSYM B12 assay.
The AxSYM B12 assay is a Microparticle Enzyme Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum or plasma. The AxSYM B12 assay is calibrated with Abbott B12 Calibrators. Abbott B12 Controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.
The Abbott AxSYM® B12 assay is intended for the quantitative determination of vitamin B12 in human serum or plasma. The study conducted to demonstrate its safety and effectiveness compared its performance against the Abbott ARCHITECT® B12 assay, as stated in the 510(k) summary (K051327).
1. Table of acceptance criteria and the reported device performance
The provided document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for slope, intercept, or correlation coefficient. However, the performance is reported through a correlation analysis. Since the conclusion states that the device is "substantially equivalent" to the predicate, it implies that the reported performance values were deemed acceptable by the FDA for this determination.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (AxSYM B12 vs. ARCHITECT B12) |
|---|---|---|
| Correlation (r) | High (close to 1) | 0.98 |
| Slope (Least Squares) | Close to 1 | 1.09 |
| Intercept (Least Squares) | Close to 0 | 3.7 |
| Slope (Passing-Bablok) | Close to 1 | 1.12 |
| Intercept (Passing-Bablok) | Close to 0 | -13.9 |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: n = 441 specimens.
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's a quantitative diagnostic test, these are typically clinical samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. For this type of in vitro diagnostic device, the "ground truth" is typically another established, legally marketed diagnostic assay (the predicate device, in this case, the Abbott ARCHITECT® B12 assay), not expert consensus from radiologists or similar medical specialists.
4. Adjudication method for the test set
Not applicable. The study involves a direct comparison of quantitative results between two assays, not the interpretation of results by multiple human readers that would require an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This was not an MRMC study. This study evaluated the performance of an in vitro diagnostic device (a blood assay) against a predicate device, not the effectiveness of AI assistance for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The study evaluated the performance of the AxSYM B12 assay (which operates independently of human interpretation of the results through an algorithm) against the ARCHITECT B12 assay. The "algorithm" here refers to the underlying chemical and analytical processes of the assay, not an AI algorithm.
7. The type of ground truth used
The "ground truth" for the performance study was established by the Abbott ARCHITECT® B12 assay, which is the legally marketed predicate device to which the AxSYM B12 assay was compared for substantial equivalence.
8. The sample size for the training set
This information is not applicable and not provided. Clinical diagnostic assays like the AxSYM B12 are developed and validated using a different process than machine learning algorithms, which typically involve distinct training and test sets. The calibration of the AxSYM B12 assay is done with Abbott B12 Calibrators, but this is not analogous to a machine learning training set sample size.
9. How the ground truth for the training set was established
This information is not applicable. As stated above, this is not a machine learning study with a "training set" in the conventional sense. The assay is calibrated using specific Abbott B12 Calibrators, which are themselves traceable to a known standard for vitamin B12 concentration.
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K 051327
510(k) Summary Abbott AxSYM® 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 AxSYM B12 constitutes data supporting a substantially equivalent determination. Substantial equivalence has been demonstrated between the Abbott AxSYM B12 assay and the Abbott ARCHITECT® B12 assay. The intended use for both assays is for the quantitative determination of vitamin B12 in human serum or plasma.
The AxSYM B12 assay is a Microparticle Enzyme Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum or plasma. The AxSYM B12 assay is calibrated with Abbott B12 Calibrators. Abbott B12 Controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.
A correlation analysis between the AxSYM B12 and the ARCHITECT B12 assay yielded the following results.
| Regression Method | n | r | Slope | Intercept |
|---|---|---|---|---|
| Least Squares | 441 | 0.98 | 1.09 | 3.7 |
| Passing-Bablok | 1.12 | -13.9 |
n = number of specimens
1 = correlation coefficient
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In conclusion, these data demonstrate that the AxSYM® B12 assay is as safe and effective as, and is substantially equivalent to, the ARCHITECT® B12 assay.
Prepared and Submitted 19 May 2005 by:
Margarit Blockwick 5/19/05
Margaret Prochniak, M.S. Senior Regulatory Affairs Specialist ADD Regulatory Affairs Phone: (847) 937-4106 Fax: (847) 937-9616 E-mail: Margaret.Prochniak@abbott.com
Abbott Laboratories Diagnostics Division Department 9VA, Building AP4A-3 100 Abbott Park Road Abbott Park, IL 60064-6095
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its wing, and a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. The eagle is facing right, and the overall design is simple and monochromatic.
Re:
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Margaret Prochniak, M.S. Sr. Regulatory Affairs Specialist ADD Regulatory Affairs Abbott Laboratories Diagnostics Division Department 9VA, Building AP4A-3 100 Abbott Park Road
AUG 3 - 2005
Abbott Park, IL 60064-6095
Trade/Device Name: Abbott AxSYM® B12 Reagent Abbott AxSYM® B12 Specimen Diluent Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: Class II Product Code: CDD Dated: May 19, 2005 Received: May 20, 2005
Dear Ms. Prochniak:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benem
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K05/327
Device Name: Abbott AxSYM® B12 Reagent Abbott AxSYM® B12 Specimen Diluent
Indications For Use:
The AxSYM B12 reagent is a microparticle enzyme intrinsic factor assay for the quantitative determination of vitamin B12 in human serum or plasma on the AxSYM System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
The AxSYM B12 Specimen Diluent is used for manually diluting specimens for testing using the AxSYM B12 assay.
Prescription Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k). K051327
§ 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.