(15 days)
The Abbott ARCHITECT B12 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of vitamin B12 in human serum and plasma.
The Abbott ARCHITECT B12 Calibrators are liquid, ready-for-use materials in a buffered aqueous solution. Concentrations of the calibrator components span the dynamic range of the assay.
The provided text describes the Abbott ARCHITECT® B12 Calibrators, which are for calibrating the ARCHITECT i System for quantitative determination of vitamin B12 in human serum and plasma. The study presented is a correlation analysis between the new 6-Point Calibrators and the predicate 2-Point Calibrators.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are not explicitly stated in the provided text. However, the study aims to demonstrate that the performance of the new 6-Point Calibrators is "comparable to the performance of the predicate device." The reported performance metrics are based on a correlation analysis.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (6-Point vs. 2-Point Calibrators) |
|---|---|---|
| Correlation (r) | High correlation (e.g., close to 1) | 0.998 |
| Slope (Least Squares) | Close to 1 | 0.96 |
| Intercept (Least Squares) | Close to 0 | 22 |
| Slope (Passing-Bablok) | Close to 1 | 0.98 |
| Intercept (Passing-Bablok) | Close to 0 | 12 |
2. Sample size used for the test set and the data provenance
- Sample size used for the test set: 495 specimens
- Data provenance: Not explicitly stated, but the specimens were "serum specimens tested." The country of origin and whether the data was retrospective or prospective are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the text. The study is a comparison of two calibration methods, not a diagnostic test requiring expert ground truth in the traditional sense. The "ground truth" here is the measurement obtained by the predicate device's 2-Point Calibrators.
4. Adjudication method for the test set
This information is not applicable as it's a direct comparison of calibration methods and not a study requiring adjudication of diagnostic interpretations by experts.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a calibrator for an automated assay, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not entirely applicable in the context of a calibrator for an automated immunoassay. The device is a component that enables standalone (algorithm-only, or in this case, instrument-only) performance of the ARCHITECT i System for B12 measurement. The study directly assesses the performance of this calibrator in conjunction with the instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this study is essentially the results obtained using the predicate device's 2-point calibration assay. The new 6-point calibrators are being evaluated against the established performance of the existing calibrators.
8. The sample size for the training set
This information is not provided and is likely not relevant for this type of calibrator evaluation. Calibrators are developed based on specific chemical and manufacturing processes, not typically "trained" on large datasets in the way an AI algorithm would be.
9. How the ground truth for the training set was established
This information is not provided and is likely not applicable for the reasons stated in point 8.
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K 053330
Special 510(k) Summary Abbott ARCHITECT® B12 Calibrators
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
According to the requirements of 21 CFR §807.92, the following information provides of According to the requirements of DF OFF 30 for a determination of substantial equivalence.
| Submitter's Name and Address: | Abbott LaboratoriesDiagnostics Division100 Abbott Park RoadAbbott Park, IL 60064Telephone: (847) 937-4106Fax: (847) 937-9616Contact: Margaret.Prochniak@abbott.com |
|---|---|
| ------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Date Prepared: 29 November 2005
| Device Proprietary Name:Device Common Name:Classification Number: | Abbott ARCHITECT® B12 CalibratorsVitamin B12Clinical Chemistry, 21 CFR §862.1150 |
|---|---|
| Predicate Device: | Abbott ARCHITECT® B12510(k) Number: K984108Concurrence Date: 3 February 1999 |
| Device Description: | The Abbott ARCHITECT B12 Calibrators areliquid, ready-for-use materials in a bufferedaqueous solution. Concentrations of the calibratorcomponents span the dynamic range of the assay. |
| Intended Use: | The Abbott ARCHITECT B12 Calibrators are forthe calibration of the ARCHITECT i System whenused for the quantitative determination of vitaminB12 in human serum and plasma. |
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A correlation analysis was performed between the ARCHITECT B12 6-Point Calibrators and the ARCHITECT 2-Point Calibrators. In this evaluation, serum specimens tested and the ARCHITECT 2-1 only Callorations in The ARCHITECT B12 6-point calibration assay, and from 77 to 1988 pg/mL by the ARCHITECT B12 2-point calibration assay. The evaluation yielded the following results:
| Regression Method | N | r | Slope | Intercept |
|---|---|---|---|---|
| Least Squares | 495 | 0.998 | 0.96 | 22 |
| Passing-Bablok | 495 | 0.998 | 0.98 | 12 |
n = number of specimens
r = correlation coefficient
In conclusion, these data demonstrate that the performance of the Abbott ARCHITECT In conclusion, intese uata demonstrate and comparable to the performance of the predicate device, when used according to its intended use.
Prepared and Submitted 29 November 2005 by:
Margaret Bochniak 11/29/05
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 AP6C-2 100 Abbott Park Road Abbott Park, IL 60064-6095
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes representing the feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 16 2005
Ms. Margaret Prochniak, M.S. Sr. Regulatory Affairs Specialist Abbott Laboratories Diagnostics Division Dept. 9VA, Bldg. AP 6C-2 100 Abbott Park Road Abbott Park, IL 60064-6095
Re: K053330
Trade/Device Name: Abbott ARCHITECT® B12 Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: November 29, 2005 Received: December 1, 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,
Alberto Guti
Alberto Gutierrez, Ph.D. 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): K 053330
Device Name: Abbott ARCHITECT® B12 Calibrators
Indications For Use:
The Abbott ARCHITECT B12 Calibrators are for the calibration of the The Abbott ARCHITECT BT2 Canbrators are for the canoration of vitamin B12 in human serum and plasma.
Prescription Use _ X (Part 21 CFR 801 Subpart D) 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)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K053330
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.