(19 days)
Architect Total T3 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Total T3 assay on the Abbott Architect i System.
Architect Total T3 MasterCheck Level 0 contains human serum.
Architect Total T3 MasterCheck Levels 1, 2, and 3 contain Total T3 prepared in human serum.
Preservative: Sodium Azide.
I am sorry, but the provided text appears to be a 510(k) summary for a diagnostic control device (Architect Total T3 MasterCheck) and does not contain information about studies proving the device meets acceptance criteria in the way described by your request (e.g., performance metrics like accuracy, sensitivity, specificity, or studies involving human readers or ground truth established by experts).
The document is a regulatory submission outlining:
- Device Name: Architect Total T3 MasterCheck
- Intended Use: Verification of sensitivity, calibration linearity, and reportable range of the Total T3 assay on the Abbott Architect i System.
- Classification: Class I, 75JJX CFR 862.1660: Single (Specified) Analyte Controls (Assayed and Unassayed).
- Predicate Device: Casco Standards Document Serum Multi-Analyte Verification Test Set (K950469).
- Technological Characteristics Comparison: A table comparing Architect Total T3 MasterCheck to the predicate device, highlighting similarities and some differences (like analytes and open vial claim).
- FDA Clearance: A letter from the FDA confirming substantial equivalence to a legally marketed predicate device.
This type of submission for a Class I control device typically focuses on demonstrating similarity to an existing device, manufacturing controls, and intended use, rather than extensive clinical performance studies that would involve establishing ground truth from patient data or evaluating human reader performance.
Therefore, I cannot provide the requested information as it is not present in the given text.
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K98432-7
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Laboratories
Diagnostics Group 500 Jeronimo Road Irvine, California 92618-20 Telephone: (949) 598-12
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 Total T3 MasterCheck
Classification Name Class I. 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 Total T3 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Total T3 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. The logo is in a black rounded rectangle. The text "BIO-RAD" is in white, bold, sans-serif font.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Architect Total T3 MasterCheck Level 0 contains human serum.
Architect Total T3 MasterCheck Levels 1, 2, and 3 contain Total T3 prepared in human serum.
Preservative: Sodium Azide.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Bio-Rad Architect Total T3 MasterCheck and the devices to which substantial equivalence is claimed.
| Architect Total T3 MasterCheck | Casco Standards DocumentSerum Multi-AnalyteVerification Test Set | |
|---|---|---|
| IntendedUse | Verification of sensitivity,calibration linearity, andreportable range of the TotalT3 assay 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 | Human Serum | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | Total T3 | Multiple |
| Open VialClaim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for theArchitect Total T3 assay | Calibration verifier formultiple analytes. |
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or other bird-like figure with its wings spread, positioned to the right of the text. The text, arranged in a circular fashion around the bird, reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
DEC 22 1990
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Staff Regulatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K984327 Trade Name: Architect Total T3 MasterCheck Requlatory Class: I Product Code: JJX 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 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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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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 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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510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Device Name: Architect Total T3 MasterCheck
Indications for Use:
Architect Total T3 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Total T3 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 K984327
| 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.