(36 days)
Architect Estradiol MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Estradiol assay on the Abbott Architect i System.
Architect Estradiol MasterCheck Level 0 contains TRIS buffer with protein (bovine) stabilizers.
Architect Estradiol MasterCheck Levels 1, 2, 3 and 4 contain estradiol prepared in TRIS buffer with protein (bovine) stabilizers.
Preservative: Antimicrobial Agent.
This document is a 510(k) summary for the Bio-Rad Architect Estradiol MasterCheck and does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study demonstrating the device meets those criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory approval. It does not include:
- A table of specific acceptance criteria (e.g., performance metrics, thresholds) for the device's function (sensitivity, calibration linearity, reportable range verification).
- Details of a study proving the device meets specific predefined acceptance criteria.
- Information about sample sizes for a test set, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
- Information about training sets or their ground truth establishment.
However, based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with numerical performance targets or reported device performance against those targets. The "Statement of Intended Use" on page 0 and "Indications for Use" on page 4 define the intended functions, which implicitly represent the high-level criteria the device is expected to meet:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Verification of sensitivity of the Estradiol assay | Not specified in this document |
| Verification of calibration linearity of the Estradiol assay | Not specified in this document |
| Verification of reportable range of the Estradiol assay | Not specified in this document |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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 information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This document describes a diagnostic control product, not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not applicable and therefore, not performed or mentioned here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes a diagnostic control product, not an algorithm, so standalone algorithm performance is not applicable and therefore, not performed or mentioned here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. For a control material, "ground truth" would typically refer to the known, characterized concentrations of analytes within the control materials themselves, established through validated reference methods. However, the details of how these concentrations were established are not described here.
8. The sample size for the training set
This document describes a diagnostic control product, not a machine learning algorithm that requires a training set. Therefore, this question is not applicable.
9. How the ground truth for the training set was established
This question is not applicable as it pertains to machine learning algorithms, which is not the subject of this document.
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boratories
one: (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 21, 1998
Device (Trade & Common Name) Architect Estradiol 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 Estradiol MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Estradiol assay on the Abbett Architect i System.
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Blo-Rad Laboratories Diagnostics Gmun Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Architect Estradiol MasterCheck Level 0 contains TRIS buffer with protein (bovine) stabilizers.
Architect Estradiol MasterCheck Levels 1, 2, 3 and 4 contain estradiol prepared in TRIS 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 Estradiol MasterCheck and the devices to which substantial equivalence is claimed.
| Architect Estradiol MasterCheck | Casco Standards DocumentSerum Multi-AnalyteVerification Test Set | |
|---|---|---|
| IntendedUse | Verification of sensitivity,calibration linearity, andreportable range of the Estradiolassay 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 | TRIS buffer with protein (bovine)stabilizers. | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | Estradiol | Multiple |
| Open VialClaim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for theArchitect Estradiol assay. | Calibration verifier formultiple analytes. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows a stylized logo or emblem, possibly associated with a department or organization. The logo features a series of three curved, overlapping shapes that resemble stylized waves or swooshes. The text "DEPART" is oriented vertically and rotated, and the text "OF HEALTH & HUMAN" is also oriented vertically and rotated.
2 1999 EEB
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
K984604 Re:
Trade Name: Architect™ Estradiol MasterCheck Regulatory Class: I Product Code: 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 stated in also 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 Connistions 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 (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 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 vitto 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 Butman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
V
Enclosure
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Page 1 of 1
3
510(k) Number: K984604
Device Name: Architect Estradiol MasterCheck
Indications for Use:
Architect Estradiol MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Estradiol assay on the Abbott Architect i System.
Sean Cooper
u: Sign-Off) on of Clinical Laboratory Devices K984604 Ak) Mumber
(Please Do NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
Prescription Use \checkmark 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.