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

Device Description

Architect Folate MasterCheck Level 0 contains boratc buffer. Architect Folate MasterCheck Levels 1, 2, 3 and 4 contain pteroyIglutamic acid (PGA) prepared in citrate buffer with protein (bovine) stabilizers. Preservative: Antimicrobial Agent.

AI/ML Overview

The provided text is a 510(k) summary for the Bio-Rad Architect Folate MasterCheck, an in vitro diagnostic device. This type of document focuses on establishing substantial equivalence to a predicate device rather than detailing extensive clinical study results for novel device performance. Therefore, many of the requested elements for a typical medical device study, particularly those related to human readers, experts, training sets, and complex performance metrics like AUC or effect sizes, are not directly applicable or available in this specific document.

The document primarily describes the device, its intended use, and compares its technological characteristics to a predicate device to demonstrate substantial equivalence.

Here's an attempt to answer your questions based on the provided text, while acknowledging the limitations of this type of regulatory submission:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" for a novel device's performance (e.g., sensitivity, specificity, accuracy) is not explicitly detailed in the way one might expect for a new diagnostic algorithm. Instead, the "acceptance criteria" here are implicitly related to demonstrating that the Architect Folate MasterCheck maintains fundamental characteristics (like intended use, form, matrix, storage, and analytes) that are substantially equivalent to the Casco Standards Document Serum Multi-Analyte Verification Test Set. The "performance" described pertains to its functional role as a calibration verifier.

The document does not provide specific numerical performance metrics (e.g., sensitivity, specificity, or AUC) for the Architect Folate MasterCheck in the context of diagnosing a condition. Instead, its performance is described in terms of its intended function: "verification of sensitivity, calibration linearity, and reportable range of the Folate assay on the Abbott Architect i System." Since it's a control/verifier and not a diagnostic device itself, the "reported device performance" is its formulation and its intended functional use matching that of a predicate.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance (Characteristics)
Intended Use: Verification of sensitivity, calibration linearity, and reportable range for folate assays.	Intended Use: Verification of sensitivity, calibration linearity, and reportable range of the Folate assay on the Abbott Architect i System. (Matches predicate's broader use for linearity/calibration verification)
Form: Liquid.	Form: Liquid. (Matches predicate)
Matrix: Contains stabilizers (or similar to predicate's matrix).	Matrix: Citrate buffer with protein (bovine) stabilizers. (Different from predicate's human serum, but considered acceptable for its intended function)
Storage: Defined temperature range.	Storage: 2-8°C. (Different from predicate's -10 to -20°C, but defined)
Analytes: Specific to Folate.	Analytes: Folate. (A subset of predicate's "Multiple" analytes, but specific)
Open Vial Claim: Defined stability after opening.	Open Vial Claim: 3 Days at 2-8°C. (Different from predicate's 30 days, but defined)

Study Proving Acceptance Criteria:

The "study" referenced is the 510(k) submission itself, which presents information to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This is a regulatory pathway, not a traditional clinical trial designed to prove device performance against a gold standard for a diagnostic claim. The document highlights the similarities and differences, arguing that the differences do not raise new questions of safety or effectiveness.

Sample size used for the test set and the data provenance: This information is not provided in a way that aligns with a typical "test set" for performance evaluation of a diagnostic algorithm. The document describes the composition of Architect Folate MasterCheck (Level 0 and Levels 1, 2, 3, and 4) which contains specific components (borate buffer, pteroylglutamic acid, citrate buffer with bovine protein stabilizers). No specific sample size (i.e., number of biological samples or measurements) is given for a "test set" for performance in the diagnostic sense. The comparison is primarily about the product's chemical and physical characteristics and intended use. The data provenance is not specified, as it's a product description and comparison.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe the establishment of ground truth for a diagnostic performance test set, as the device is a control/verifier, not a diagnostic test.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept applies to human-read diagnostic studies, which this is not.
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 an in vitro diagnostic control/verifier. It does not involve human readers for interpretation, nor does it incorporate AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be its certified concentrations of Folate, which are established during manufacturing for its role as a control/calibrator, not clinical ground truth for a disease state.
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device that requires a training set.

Summary

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K984625

Image /page/0/Picture/2 description: The image shows the logo for BIO-RAD. The text is white and bolded, and it is set against a black background. The background is in the shape of a rounded rectangle.

Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (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 Folate 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

STATUS CARDER CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSUL

Architect Folate MasterCheck is intended for use in the verification of sensitivity. calibration linearity, and reportable range of the Folate 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 Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is a black rectangle with rounded corners, and the words "BIO+RAD" are written in white letters inside the rectangle. The plus sign is slightly smaller than the other letters. The logo is simple and recognizable.

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

Description of the Device

Statement of How Technological Characteristics Compare to Substantial Equivalence Device

A table is provided below comparing the similarities between the Bio-Rad Architect Folate MasterCheck and the devices to which substantial equivalence is claimed.

	Architect Folate MasterCheck	Casco Standards DocumentSerum Multi-AnalyteVerification Test Set
IntendedUse	Verification of sensitivity,calibration linearity, andreportable range of the Folateassay 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	Citrate buffer with protein(bovine) stabilizers.	Human Serum
Storage	2-8°C	-10 to -20°C
Analytes	Folate	Multiple
Open VialClaim	3 Days at 2-8°C.	30 Days at 2-8°C.
Differences	Calibration verifier for theArchitect Folate assay.	Calibration verifier formultiple analytes

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2 1999 FEB

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

Re: K984625

Trade Name: Architect™ Folate 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 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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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 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 Autman

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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K984625 510(k) Number: Device Name: Architect Folate MasterCheck

Indications for Use:

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

Jean Cooper
(Division Sign-Off)

ision of Clinical Laboratory Devices K984625 510(k) Number _

(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.