(14 days)
Architect Ferritin MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Ferritin assay on the Abbott Architect i System.
Architect Ferritin MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect Ferritin MasterCheck Levels 1, 2, 3 and 4 contain ferritin (human) prepared in HEPES buffer with protein (bovine) stabilizers.
Preservative: Antimicrobial Agent.
The provided text is related to the 510(k) submission for the Architect Ferritin MasterCheck device. This device is a single-analyte control intended for the verification of sensitivity, calibration linearity, and reportable range of the Ferritin assay on the Abbott Architect i System.
It's important to understand that this submission is for a control material, not a diagnostic device that performs measurements or interpretations. Therefore, the "acceptance criteria" and "device performance" in the context of this document are related to the control material itself and its chemical characteristics, rather than the diagnostic accuracy of a measurement or an AI algorithm.
The document does not contain information on the acceptance criteria or a study proving the device meets those criteria in the way you've outlined for diagnostic devices or AI algorithms. Your requested information (sample sizes, ground truth, experts, MRMC studies, standalone performance, training sets, etc.) is typically associated with evaluating the performance of diagnostic tests or AI systems that interpret data, not with the characterization of a control material like the Architect Ferritin MasterCheck.
Here's a breakdown of why this document doesn't fit your requested format:
- No Diagnostic Performance Evaluation: The document describes a "MasterCheck" and its intended use as a "verification of sensitivity, calibration linearity, and reportable range." This means it's used to check if the assay (on the Abbott Architect i System) is performing correctly, not to perform a diagnosis itself or to be evaluated for its diagnostic accuracy.
- No AI Component: There is no mention of any artificial intelligence, machine learning, or algorithm in this submission.
- No Clinical Study for Performance: The document does not describe a clinical study to evaluate its performance against diseases or conditions. Instead, it compares its technological characteristics to a predicate device (Casco Standards Document Serum Multi-Analyte Verification Test Set) to establish substantial equivalence.
Therefore, I cannot populate your requested table and information based on the provided text because the nature of the device (a control material) and the content of the 510(k) summary do not include the type of performance data you are asking for.
The document's focus is on:
- Intended Use: Verifying the performance of another assay.
- Device Description: Chemical composition (HEPES buffer, bovine protein, human ferritin, antimicrobial agent).
- Comparison to Predicate: Highlighting similarities in intended use, form, matrix, storage, analytes, open vial claim, and differences (e.g., specific to the Architect Ferritin assay vs. multiple analytes).
- Regulatory Classification: Class I, product code JJX, CFR 862.1660.
If you have a document describing a diagnostic device or an AI-powered medical device, I would be able to apply your requested structure.
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DEC 1 7 1998
Image /page/0/Picture/2 description: The image shows the Bio-Rad logo. The logo is white text on a black rounded rectangle. The text reads "BIO+RAD" in all caps.
Bio-Rad Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
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 02, 1998
Device (Trade & Common Name) Architect Ferritin 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 Ferritin MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Ferritin assay on the Abbott Architect i System.
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Description of the Device
Architect Ferritin MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect Ferritin MasterCheck Levels 1, 2, 3 and 4 contain ferritin (human) prepared in HEPES 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 similanties between the Bio-Rad Architect Ferritin MasterCheck and the devices to which substantial equivalence is claimed.
| Architect Ferritin MasterCheck | Casco Standards DocumentSerum Multi-AnalyteVerification Test Set | |
|---|---|---|
| IntendedUse | Verification of sensitivity,calibration linearity, andreportable range of the Ferritinassay on the Abbott Architect iSystem. | In vitro diagnostic use in thequantitative determination oflinearity, calibrationverification and verificationof reportable range usingautomated, semi-automatedand manual methods. |
| Form | Liquid | Liquid |
| Matrix | HEPES buffer with protein(bovine) stabilizers | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | Ferritin | Multiple |
| Open VialClaim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for theArchitect Ferritin assay | Calibration verifier formultiple analytes. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the profile images.
DEC 1 7 1998 Ms. Elizabeth Platt Requlatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K984325 Architect Ferritin MasterCheck Trade Name: Regulatory Class: I Product Code: JJY Dated: December 2, 1998 Received: December 3, 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 leqally 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 qeneral 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 Requlations, 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 Requlation (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 Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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
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 requlation 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 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: _______________________________________________________________________________________________________________________________________________________________ Device Name: Architect Ferritin MasterCheck
Indications for Use:
Architect Ferritin MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Ferritin assay on the Abbott Architect i System.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K984315 |
| 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.