(12 days)
Architect LH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott Architect i System.
Architect LH MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect LH MasterCheck Levels 1, 2, and 3 contain LH (human) prepared in HEPES buffer with protein (bovine) stabilizers.
Preservative: Antimicrobial Agent.
I am sorry, but the provided document does not contain the detailed information required to fill out the table and answer all the questions regarding acceptance criteria and a study proving the device meets them.
The document is a 510(k) summary for the Bio-Rad Architect LH MasterCheck, which is a control device for an LH assay. It focuses on establishing substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria for the new device.
Specifically, the document does not include:
- A table of acceptance criteria for the Architect LH MasterCheck's performance.
- Reported device performance metrics against specific criteria.
- Information about sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, or adjudication methods for test sets.
- Details on a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes related to human reader improvement with AI.
- Standalone algorithm performance data.
- The type of ground truth used (beyond implying it's for verifying assay performance, not a diagnostic outcome).
- Sample size for a training set.
- How ground truth for a training set was established.
The content mainly provides:
- Intended Use: Verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott Architect i System.
- Device Description: Composition of the control levels.
- Comparison to Predicate Device: A table comparing characteristics like intended use, form, matrix, storage, analytes, and open vial claim.
- Regulatory Information: 510(k) clearance letter.
Therefore, I cannot extract the requested information from this document.
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DEC 15 1998
Image /page/0/Picture/1 description: The image shows the logo for BIO-RAD. The logo is white text on a black background. The text is in all capital letters and is bolded.
Bio-Rad Laboratories
Diagnostics Group 0 Jeronimo Road Irvine, California 92618-2017 lephone: (949) 598-1200
984323
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 LH 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 LH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the LH 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 white text on a black background. The text is in a bold, sans-serif font. The logo is enclosed in a rounded rectangle.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Architect LH MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect LH MasterCheck Levels 1, 2, and 3 contain LH (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 similarities between the Bio-Rad Architect LH MasterCheck and the devices to which substantial equivalence is claimed.
| Architect LH MasterCheck | Casco Standards DocumentSerum Multi-AnalyteVerification Test Set | |
|---|---|---|
| IntendedUse | Verification of sensitivity,calibration linearity, andreportable range of the LHassay 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 | LH | Multiple |
| Open VialClaim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for theArchitect LH assay | Calibration verifier formultiple analytes. |
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, with three lines representing the wings and body. The eagle is facing to the right.
DEC 15 1998
Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
Re : K984323 Architect LH MasterCheck Trade Name: 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 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 Regulation (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 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 obliqation 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 requlations.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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Paqe 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 requlation (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 Sutman
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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1984323 510(k) Number: Device Name: Architect LH MasterCheck
Indications for Use:
Architect LH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott Architect i System.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K984323
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
Prescription Use __
Over-The Counter Use OR
§ 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.