The ARCHITECT BNP assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma on the ARCHITECT i System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.

The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information.

The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators, and instrument), when used for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information.

Device Description

ARCHITECT BNP assay is a two-step immunoassay for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma using CMIA technology with flexible assay protocols, refereed to as Chemiflex®.

In the first step, sample and anti-BNP coated paramagnetic microparticles are combined. BNP present in the sample bind to the anti-BNP coated microparticles. After washing, anti-BNP acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of BNP in the sample and the RLUs detected by the ARCHITECT i System optics.

For additional information on system and assay technology, refer to the ARCHITECT System Operations Manual, Section 3.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the ARCHITECT® BNP Assay based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (ARCHITECT BNP vs. AxSYM BNP)
Correlation Coefficient (r) (intended to show strong agreement with predicate)	0.96
Intercept (95% CI) (intended to be close to 0 for good agreement)	-38.32 (-48.26 to -28.50)
Slope (95% CI) (intended to be close to 1 for good agreement)	1.03 (0.98 to 1.09)
Sample Range (ARCHITECT)	0-3702 pg/mL
Sample Range (AxSYM)	50 - 3103 pg/mL

Note: The acceptance criteria themselves are not explicitly stated as numerical targets (e.g., "correlation coefficient > 0.95"). Instead, the study aims to demonstrate substantial equivalence to the predicate device, the AxSYM BNP Assay, through strong correlation and a Passing-Bablok regression analysis indicating a close relationship (slope near 1, intercept near 0). The reported performance demonstrates this strong correlation.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 171 individuals
Data Provenance: The samples were collected from "populations of individuals with and without heart failure." No specific country of origin is mentioned, but the context implies it was likely collected from a clinical setting relevant to the US market where the submission is being made. The samples were EDTA plasma samples. The study is a single instance comparison, implying retrospective collection for this specific comparison study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study compares the ARCHITECT BNP assay to a predicate device (AxSYM BNP assay), and the "ground truth" for the comparison is essentially the results obtained from the predicate device. Therefore, no external experts were used to establish a separate ground truth for the test set, beyond the established clinical use and validation of the predicate device itself.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth was based on comparison to the predicate device, not on independent expert adjudication of clinical outcomes or diagnoses.

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 applicable. The device is an in vitro diagnostic (IVD) assay for quantitative determination of a biomarker, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the study described is a standalone performance comparison between two assay devices (ARCHITECT BNP vs. AxSYM BNP). The ARCHITECT BNP assay is a laboratory test that provides quantitative results directly; it does not involve human interpretation in a human-in-the-loop scenario. The performance described (correlation, slope, intercept) is the direct output of the instrument.

7. The Type of Ground Truth Used

The "ground truth" for this study is the results obtained from the predicate device (ABBOTT AxSYM® B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (MEIA) Test). The study aimed to demonstrate substantial equivalence to this legally marketed predicate device.

8. The Sample Size for the Training Set

This information is not provided as this document describes a comparison study, not the development or training of the ARCHITECT BNP assay itself. The ARCHITECT BNP is a chemiluminescent immunoassay, not a machine learning model that requires a "training set" in the conventional sense. The "training" of such a device primarily involves internal development, optimization, and calibration protocols which are generally not disclosed in typical 510(k) summaries for IVD devices.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not directly relevant to the type of device and the presented study. As mentioned above, the ARCHITECT BNP assay is a biochemical immunoassay, not an AI/ML device that requires a labeled "training set" with ground truth in the same way.

Summary

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _

MAY 2 5 2006

Submitter Information

Address:	Fujirebio Diagnostics, Inc.201 Great Valley ParkwayMalvern, PA 19355
Contact person:	Diana L. Wolaniuk, (610) 240-3917
Summary preparation date:	April 4, 2006
Name of Device
Trade/Proprietary Name:	ARCHITECT® BNP Assay
Common/Usual Name:	BNP (B-Type Natriuretic Peptide) Test

Predicate Device

Classification Name:

ABBOTT AxSYM® B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (MEIA) Test

Test, Natriuretic Peptide

Device Description

For additional information on system and assay technology, refer to the ARCHITECT System Operations Manual, Section 3.

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Intended Use

Reagent Kit

Calibrator Kit

Control Kit

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Statement of Substantial Equivalence

The ARCHITECT BNP Assay kit is substantially equivalent to the AxSYM BNP Assay. Both of the devices are IVD products and are indicated for the quantitative determination of BNP assay values (human B-type natriuretic peptide) and used as an aid in the diagnosis and assessment of severity of heart failure.

A study was performed with guidance from NCCLS Protocol EP9-A2' to compare the ARCHITECT BNP assay to the AxSYM BNP assay. EDTA plasma samples form 171 individuals (128 heart failure patients, 43 non-heart failure individuals) were tested with both assays. These samples were collected from populations of individuals with and without heart failure. The results from the Passing-Bablok2 linear regression analysis is summarized in the following table. *

ARCHITECT BNP vs. AxSYM BNP
RegressionMethod	SpecimenType	N	CorrelationCoefficient	Intercept(95% CI)	Slope(95% CI)
Passing-Bablok**	EDTAPlasma	171	0.96	-38.32(-48.26 to -28.50)	1.03(0.98 to 1.09)

Sample Range (ARCHITECT): 0-3702 pg/mL Sample Range (AxSYM): 50 - 3103 pg/mL

Representative data; variables such as differences in sampling size and population may impact the correlation of the assay. Therefore, results in individual laboratories may vary from these data. .

** A linear regression method with no special assumptions regarding the distribution of the samples and measurement errors.

1 National Committee for Clinical Laboratory Standards. Method comparison and bias estimation using patient samples; Approved Guideline-Second Edition. NCCLS Document EP9-A2, Wayne, PA: NCCLS, 2002.

2 Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. J Clin Chem Clin Biochem 1983; 21(11)709-20.

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A comparison of the features of the ARCHITECT BNP assay device and the AxSYM BNP assay device are as follows:

	ARCHITECT BNP(Proposed Device)	AxSYM BNP(Predicate Device)K033606
Device Type	In vitro diagnostic	In vitro diagnostic
Classification andProduct Code	Class II, NBC	Class II, NBC
Principle of Operation	Chemiluminscent MicroparticleImmunoassay (CMIA)	Microparticle EnzymeImmunoassay (MEIA)
Product Usage	Clinical and Hospitals laboratories	Clinical and Hospitals laboratories
Intended Use	The ARCHITECT BNP assay is achemiluminescent microparticleimmunoassay (CMIA) for thequantitative determination ofhuman B-type natriuretic peptide(BNP) in human EDTA plasma onthe ARCHITECT i System. BNPvalues are used as an aid in thediagnosis and assessment ofseverity of heart failure.	AxSYM BNP is a MicroparticleEnzyme Immunoassay (MEIA) forthe quantitative determination ofhuman B-type natriuretic peptide(BNP) in human EDTA plasma onthe AxSYM System. BNP valuesare used as an aid in the diagnosisand assessment of severity ofheart failure.
Type of Specimen	EDTA Plasma	EDTA Plasma
Specimen CollectionMethod	Plastic collection tubes	Plastic collection tubes
Capture Antibody	Anti-BNP (106.3) mousemonoclonal	Anti-BNP (106.3) mousemonoclonal
Conjugate Antibody	Anti-BNP (BC203) mousemonoclonal	Anti-BNP (BC203) mousemonoclonal
Calibrator	6 levels (0 - 5000 pg/mL)	6 levels (0 - 4000 pg/mL)
Controls	3 levels (Low = 90 pg/mL,Medium = 500 pg/mL, High =3500 pg/mL)	3 levels (Low = 100 pg/mL,Medium = 440 pg/mL, High =1500 pg/mL)
Interpretation of Results	Calibrator CurveA direct relationship existsbetween the amount of BNP in thesample and the light detected bythe instrument system	Calibrator CurveA direct relationship existsbetween the amount of BNP in thesample and the light detected bythe instrument system

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Diana L. Wolaniuk Clinical and Regulatory Affairs Specialist Fujirebio Diagnostics, Inc. 201 Great Valley Parkway - Malvern, PA 19355

MAY 2 5 2006

Re: K060964

Trade/Device Name: ARCHITECT® BNP ARCHITECT BNP Reagent Kit ARCHITECT BNP Calibrator Kit ARCHITECT BNP Control Kit

Regulation Number: 21 CFR§862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class II Product Code: NBC, JIT, JJX Dated: April 5, 2006 Received: April 7, 2006

Dear Ms. Wolaniuk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 --

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto G

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K060964

Device Name: ARCHITECT® BNP

Indications For Use:

ARCHITECT BNP Reagent Kit

ARCHITECT BNP Calibrator Kit

ARCHITECT BNP Control Kit

The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators, and instrument), when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benson
Division Sign-Off

Page 1 of 1

Office of In Vitro Diagnostic Device Evaluation and Safety

s(k) K060964

349

Regulation Number and Section

§ 862.1117 B-type natriuretic peptide test system.

(a)
Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.(b)
Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”