Architect Free T4 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System

Device Description

Architect Free T4 MasterCheck Level 0 contains human serum Architect Free T4 MasterCheck Levels 1, 2 and 3 contain Free T4 prepared in human serum. Preservative: Sodium Azide.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Architect FreeT4 MasterCheck." This document focuses on the regulatory submission and comparison of the device to a predicate device, rather than a clinical study evaluating its acceptance criteria and performance against a specific ground truth.

Therefore, many of the requested details about acceptance criteria, study data, ground truth, and expert involvement are not available in the provided text.

Here's an analysis of what information can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of quantitative targets for performance (e.g., sensitivity, specificity, accuracy). The intended use is for "verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System." This implies that the device itself is a control or calibrator, and its "performance" would be its stability, consistency, and ability to challenge the assay being verified.
Reported Device Performance: No quantitative performance metrics (e.g., specific values for sensitivity, linearity) are reported for the Architect FreeT4 MasterCheck itself in the context of a study. The document describes its composition (human serum, Free T4) and storage claims.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Available. The document does not describe a test set or clinical study for the Architect FreeT4 MasterCheck's performance. It is a regulatory submission for a control material.

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)

Not Applicable/Not Available. As there's no described test set or ground truth establishment process for the device's performance, this information is not present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable/Not Available. Same as above.

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

Not Applicable. This device is a diagnostic control/calibrator, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This device is a diagnostic control/calibrator, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable/Not Available. There is no described study to establish ground truth for the device's performance. The "ground truth" for a control material often relates to its assigned target values, which are typically established through well-characterized reference methods or manufacturing processes. This detail is not provided.

8. The sample size for the training set

Not Applicable/Not Available. This device is a diagnostic control/calibrator, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not Applicable/Not Available. Same as above.

Summary of Available Information from the Provided Text:

Device Name: Architect FreeT4 MasterCheck
Intended Use: Verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System.
Device Type: Diagnostic control/calibrator (specifically, "Single (Specified) Analyte Controls (Assayed and Unassayed)").
Composition: Level 0 contains human serum; Levels 1, 2, and 3 contain Free T4 prepared in human serum. Preservative: Sodium Azide.
Regulatory Status: 510(k) clearance (K984070) based on substantial equivalence.
Predicate Device: Casco Standards Document Serum Multi-Analyte Verification Test Set (K950469).
Comparison to Predicate: A table outlines similarities (intended use, form, matrix) and differences (specific analytes, open vial claim, specific assay calibration).
Storage Claims: 2-8°C (Open Vial: 3 days at 2-8°C).

Conclusion:

The provided 510(k) summary focuses on the regulatory filing for a diagnostic control material rather than a performance study that would generate the detailed data requested about acceptance criteria, test sets, ground truth, and expert involvement. Such information would typically be found in a separate validation study report, not in a 510(k) summary for this type of device.

Summary

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NOV 25 1998

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Bio-Rad Laboratories

California 92618-2017 obone: (949) 598-1200

84070

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 November 10, 1998

Device (Trade & Common Name) Architect FreeT4 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 Free T4 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range 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.

Laboratories

Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200

Description of the Device

Architect Free T4 MasterCheck Level 0 contains human serum Architect Free T4 MasterCheck Levels 1, 2 and 3 contain Free T4 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 Free T4 MasterCheck and the devices to which substantial equivalence is claimed.

	Architect Free T4MasterCheck	Casco Standards DocumentSerum Multi-AnalyteVerification Test Set
IntendedUse	Verification of sensitivity,calibration linearity, andreportable range on theAbbott Architect 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	Free T4	Multiple
Open VialClaim	3 Days at 2-8°C.	30 Days at 2-8°C.
Differences	Calibration verifier for theArchitect Free T4 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 eagle with three lines forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top and left side of the circle. The text is in all caps and appears to be in a sans-serif font.

NOV 2 5 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Elizabeth Platt Staff Requlatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017

Re: K984070 Trade Name: Architect FreeT4 MasterCheck Regulatory Class: I Product Code: 75 JJX Dated: November 10, 1998 November 16, 1998 Received:

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 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

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 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: _______________________________________________________________________________________________________________________________________________________________ Architect Free T4 MasterCheck Device Name:

Indications for Use:

Architect Free T4 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range 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)

Prescription Use

OR Over-The Counter Use

Regulation Number and Section

§ 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.