(12 days)
Architect FSH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the FSH assay on the Abbott Architect i System.
Architect FSH MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect FSH MasterCheck Levels 1, 2, 3 and 4 contain FSH (human) prepared in HEPES buffer with protein (bovine) stabilizers.
Preservative: Antimicrobial Agent.
The provided text describes a 510(k) submission for the "Architect FSH MasterCheck" which is a control device for verifying the performance of FSH assays. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria for the performance of the Architect FSH MasterCheck itself as a diagnostic tool.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in this type of regulatory submission. The document defines the intended use and compares the characteristics of the new device to a predicate, not its diagnostic accuracy in a clinical setting.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not present in the document. The document describes the device's characteristics and its intended use as a verifier for an assay, but not performance metrics (e.g., sensitivity, specificity, accuracy) that would typically have acceptance criteria for a diagnostic device. The comparison table focuses on characteristics like form, matrix, storage, and analytes.
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 present. The document does not describe a "test set" in the context of evaluating diagnostic performance.
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 present. Ground truth for diagnostic performance is not discussed in this type of regulatory submission for a control device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not present.
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 information is not present. This is a control device, not an AI-assisted diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present. This is a control device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present.
8. The sample size for the training set
This information is not present. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not present.
Summary regarding the Architect FSH MasterCheck:
The document is a 510(k) summary for a control device. Its purpose is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, not to prove its diagnostic performance against a clinical ground truth through a detailed study. Therefore, the information requested regarding acceptance criteria, study design, ground truth, and expert evaluation for diagnostic performance is not relevant to this type of submission and is consequently not provided. The "study" here is essentially a comparison of the device's characteristics and intended use with a predicate device.
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DEC 1 5 1998
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Laboratories
Diagnostics Group 500 Jeronimo Road e, California 92618-2017 elephone: (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 FSH 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 FSH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the FSH assay on the Abbott Architect i System.
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Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Architect FSH MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect FSH MasterCheck Levels 1, 2, 3 and 4 contain FSH (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 FSH MasterCheck and the devices to which substantial equivalence is claimed.
| Architect FSH MasterCheck | Casco Standards DocumentSerum Multi-AnalyteVerification Test Set | |
|---|---|---|
| IntendedUse | Verification of sensitivity,calibration linearity, andreportable range of the FSHassay 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 | HEPES buffer with protein(bovine) stabilizers | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | FSH | Multiple |
| Open VialClaim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for theArchitect FSH assay | Calibration verifier formultiple analytes. |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract human form or a bird in flight, composed of three curved lines.
DEC 15 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: K984318 Architect FSH 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 Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, throuqh 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 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 beqin 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 Toutman
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 FSH MasterCheck
Indications for Use:
Architect FSH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the FSH assay on the Abbott Architect i System.
| (Division | |
|---|---|
| Divi |
| 510(k) Number | IC984318 |
|---|---|
| --------------- | ---------- |
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(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.