(32 days)
Architect B12 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the B12 assay on the Abbott Architect i System.
Architect B12 MasterCheck Level 0 contains borate buffer with protein (bovine) stabilizers.
Architect B12 MasterCheck Levels 1, 2, 3 and 4 contain cyanocobalamin prepared in borate buffer with protein (bovine) stabilizers.
Preservative: Antimicrobial Agent.
The provided text is a 510(k) Summary for the Bio-Rad Architect B12 MasterCheck device. This type of submission is for in vitro diagnostic devices (IVDs), specifically controls used to verify the performance of an assay. The information requested (acceptance criteria, study details, sample sizes, ground truth, etc.) is typically found in performance studies for diagnostic assays or prognostic devices that classify or predict outcomes in patients.
For the Bio-Rad Architect B12 MasterCheck, which is a calibration verification and linearity control, the "acceptance criteria" and "device performance" are established in a different context. These devices are designed to have known concentrations of analytes, and their performance is typically evaluated by demonstrating that they produce expected results within a specified range when tested on the target analytical system (in this case, the Abbott Architect i System for B12 assay).
Therefore, many of the requested points are not directly applicable to this specific type of device or cannot be extracted from the provided 510(k) summary. I will answer the applicable questions based on the information available:
1. A table of acceptance criteria and the reported device performance
The 510(k) summary does not explicitly state specific numerical acceptance criteria or performance data for the Architect B12 MasterCheck. For a control device, performance is typically demonstrated by showing that the manufactured lots consistently yield the expected B12 concentrations when run on the Abbott Architect i System, verifying the system's sensitivity, calibration linearity, and reportable range.
The "performance" of such a device is inherently tied to its ability to control the assay it's designed for, rather than producing diagnostic results itself. The summary implies that "performance" is a comparison of its technological characteristics to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The summary does not describe a "test set" in the context of patient samples or a diagnostic study. This device is a control product. Performance verification would involve running multiple replicates of the control material on the Abbott Architect i System. The specific number of replicates or runs for a performance verification study is not provided. Data provenance is not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The "ground truth" for a control material like Architect B12 MasterCheck is its manufactured, assigned concentration of B12. This concentration is established by the manufacturer (Bio-Rad Laboratories) through rigorous analytical methods and reference to recognized standards. It does not involve expert consensus in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" requiring adjudication in the context of diagnostic interpretation.
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
Not applicable. This device is a laboratory control, not an AI-assisted diagnostic tool, and involves no human readers or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an IVD control, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the Architect B12 MasterCheck is the assigned B12 concentration within each level of the control material. This is established through the manufacturer's gravimetric preparation and analytical value assignment processes, traceable to reference standards.
8. The sample size for the training set
Not applicable. This device is a control, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
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K98-1676
Image /page/0/Picture/1 description: The image shows the logo for Bio-Rad. The logo is white text on a black, rounded rectangle. The text is in all caps and reads "BIO-RAD".
Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-201 Telephone: (949) 598-1200
JAN 29 10000
510(k) Summary
Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation December 18, 1998
Device (Trade & Common Name) Architect B12 MasterCheck
Classification Name Class 1, 75JJX CFR 862.1660: Single (Specified) Analyte Controls (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Document Serum Multi-Analyte Verification Test Set Casco Standards Yarmouth, ME K950469
Statement of Intended Use
Architect B12 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the B12 assay on the Abbott Architect i System.
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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is a black rectangle with rounded corners, and the words "BIO-RAD" are written in white letters inside the rectangle. The letters are bold and sans-serif, and the plus sign between "BIO" and "RAD" is slightly larger than the other letters.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Architect B12 MasterCheck Level 0 contains borate buffer with protein (bovine) stabilizers.
Architect B12 MasterCheck Levels 1, 2, 3 and 4 contain cyanocobalamin prepared in borate buffer with protein (bovine) stabilizers.
Preservative: Antimicrobial Agent.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Bio-Rad Architect B12 MasterCheck and the devices to which substantial equivalence is claimed.
| Architect B12 MasterCheck | Casco Standards DocumentSerum Multi-AnalyteVerification Test Set | |
|---|---|---|
| IntendedUse | Verification of sensitivity,calibration linearity, andreportable range of the B12assay on the AbbottArchitect i System. | In vitro diagnostic use in thequantitative determination oflinearity, calibrationverification and verificationof reportable range usingautomated, semi-automatedand manual methods. |
| Form | Liquid | Liquid |
| Matrix | Borate buffer with protein(bovine) stabilizers. | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | B12 | Multiple |
| Open VialClaim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for theArchitect B12 assay. | Calibration verifier formultiple analytes. |
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Public Health Service
JAN 29 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories ECS 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K984626
Trade Name: Architect B12 MasterCheck Model #6C09-5 Regulatory Class: I Product Code: 75 JJX Dated: December 21, 1998 Received: December 28, 1998
Dear Ms. Platt:
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 (OS) 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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Page 2
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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
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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Page 1 of 1
510(k) Number: 184600 Architect B12 MasterCheck Device Name:
Indications for Use:
Architect B12 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the B12 assay on the Abbott Architect i System.
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory C 510(k) Number
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
Prescription Use
OR Over-The Counter Use
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.