(210 days)
BNP test for use on the Biosite Triage® Meter.
Abbott ARCHITECT
No
The document describes a standard in vitro diagnostic test using electrochemical detection and does not mention any AI or ML components in the device description or performance studies.
No.
The device is an in vitro diagnostic test used to measure B-Type Natriuretic Peptide (BNP) in samples, aiding in the diagnosis and assessment of congestive heart failure. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the i-STAT BNP test "can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure." This directly indicates its diagnostic purpose.
No
The device description clearly outlines hardware components including a single-use test cartridge, an i-STAT 1 Analyzer (which is thermally controlled and performs analytical steps automatically), and control materials in vials. The process involves physical sample handling and analysis within the analyzer.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the i-STAT BNP test is an "in vitro diagnostic test for the quantitative measurement of B-Type Natriuretic Peptide (BNP) in whole blood or plasma samples".
- Sample Type: It uses biological samples (whole blood or plasma).
- Purpose: It is used to measure a substance (BNP) in these samples to aid in the diagnosis and assessment of a medical condition (congestive heart failure).
- Device Description: The description details a test cartridge and analyzer system designed to perform analytical steps on the sample outside of the body.
- Controls: The description of the i-STAT BNP Controls and Calibration Verification Controls further supports its use in a diagnostic laboratory or point-of-care setting for quality control purposes.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The i-STAT BNP test is an in vitro diagnostic test for the quantitative measurement of B-twpe natriurelic peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
The cartridge is to be used with the i-STAT 1 Analyzer bearing the (Immuno) symbol, but not with the i-STAT Portable Clinical Analyzer or the Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-STAT System, the BNP test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
Product codes
NBC, JJX
Device Description
The i-STAT BNP test is contained in a single-use test cartridge. In use, the user scans a bar code and then places approximately 17 uL of whole blood or plasma in the cartridge. After the cartridge is closed, it is inserted into the thermally controlled i-STAT 1 Analyzer, and all analytical steps are performed automatically. Patient and use information may be entered into the analyzer via a keypad during the automated analysis cycle.
As the analyzer performs several quality checks and controls the temperature of the sensors via resistive heating to the underside of the sensor chips, the substrate/wash fluid is released into a conduit within the cartridge and a metered volume of the sample over the sensor chips. The enzyme-linked antibody conjugate dissolves into the sample incubates for a controlled time. The sample is then pushed into a waste chamber and the substrate/wash solution is brought over the sensors. The alkaline phosphatase captured on the BNP sensor cleaves the substrate present in the substrate/wash fluid, giving rise to an amperometric signal that is measured.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained health care professionals in accordance with a facility's policies and procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Studies established that the i-STAT BNP test is insensitive to hematocrit levels from 0 to 60 . %PCV.
- . The i-STAT BNP assay is not significantly influenced by the presence of NT-pro-BNP, ANP or CNP at 1000 pg/mL or 20,000 pg/mL.
- Studies established that there are no significant interference effects on the i-STAT BNP test . from common medications, particularly those commonly prescribed to patients with cardiovascular conditions.
- . Studies established that the lower limit of detection (LLD) for the i-STAT method is 15 pg/mL versus 5.0 pg/mL for the Triage BNP test.
- . The imprecision of the i-STAT BNP test using plasma controls was established using in-house studies. The Level 1 Control %CV was 11.1% at 126 pg/mL; the Level 2 Control %CV was 8.1% at 1551 pg/mL, and the Level 3 Control %CV was 9.8% at 3337 pg/mL. This includes within-lot, lot-to-lot, vial-to-vial, analyzer-to-analyzer, and operator-to-operator components of the imprecision.
- Studies conducted in-house compared the results of the i-STAT BNP test to those of the BNP test on the Abbott ARCHITECT. EDTA-anticoagulated samples were analyzed on both systems. The methods were compared using Deming regression analysis. N=433 for all samples, N=312 for samples where [BNP]
§ 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.”
0
510(k) Summary
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1900 and CFR 807.92.
The assigned 510(k) number is:
Summary prepared on: December 9, 2005
Submitted by:
i-STAT Corporation 104 Windsor Center Drive E. Windsor, NJ 08520 Phone: 609-443-9300 FAX: 609-443-9310
Contact:
Sue Kent - Manager, Clinical Affairs i-STAT Corporation 104 Windsor Center Drive East Windsor, NJ 08520 Phone: 609-469-0250 Fax: 609-443-9310 Email: sue.kent@i-stat.com
Establishment Registration Number: 2245578
ldentification of Device:
Test:
Device Name: i-STAT® BNP Test Proprietary/Trade Name: i-STAT® BNP Test Common Name: BNP, B-Type Natriuretic Peptide Device Classification: II Regulation Number: CFR§ 862.1117 Panel: B-Type Natriuretic Peptide Test System Product Code: NBC
Controls/calibration verification controls:
Device Name: i-STAT® BNP Control Level 1 i-STAT® BNP Control Level 2 i-STAT® BNP Control Level 3 i-STAT® BNP Calibration Verification Control Set Proprietary/Trade Name: i-STAT® BNP Control Level 1 i-STAT® BNP Control Level 2 i-STAT® BNP Control Level 3 i-STAT® BNP Calibration Verification Control Set Common Name: BNP controls, BNP calibration verification controls Device Classification: I Regulation Number: 21 CFR§ 862.1660 Panel: Single (Specified) Analyte Controls (Assayed and Unassayed)
Product Code: JJX
Identification of the Predicate Device: Test:
Device Name: BNP test for use on the Biosite Triage® Meter.
Controls/calibration verification controls:
Device Name: Triage® BNP Calibration Verification Controls
JUL 2 1 2006
1
Intended Use of the Device: Test:
The i-STAT BNP test is an in vitro diagnostic test for the quantitative measurement of B-twpe natriurelic peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
The cartridge is to be used with the i-STAT 1 Analyzer bearing the (Immuno) symbol, but not with the i-STAT Portable Clinical Analyzer or the Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-STAT System, the BNP test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
Controls:
The i-STAT BNP Controls are assayed liquid plasma used to verify the integrity of newly received i-STAT BNP cartridges.
Calibration verification controls:
The i-STAT BNP Calibration Verification Controls are assayed liguid plasma used to verify the calibration of i-STAT BNP cartridges throughout the reportable range.
Description of the Device:
Test:
The i-STAT BNP test is contained in a single-use test cartridge. In use, the user scans a bar code and then places approximately 17 u of whole blood or plasma in the cartridge. After the cartridge is closed, it is inserted into the thermally controlled i-STAT 1 Analyzer, and all analytical steps are performed automatically. Patient and use information may be entered into the analyzer via a keypad during the automated analysis cycle.
As the analyzer performs several quality checks and controls the temperature of the sensors via resistive heating to the underside of the sensor chips, the substrate/wash fluid is released into a conduit within the cartridge and a metered volume of the sample over the sensor chips. The enzyme-linked antibody conjugate dissolves into the sample incubates for a controlled time. The sample is then pushed into a waste chamber and the substrate/wash solution is brought over the sensors. The alkaline phosphatase captured on the BNP sensor cleaves the substrate present in the substrate/wash fluid, giving rise to an amperometric signal that is measured.
Controls:
The i-STAT BNP Controls are supplied in three levels packaged as six vials of one level per box with each vial containing 1 mL of control material. The three levels are in frozen liquid form, require no reconstitution or dilution, and are each comprised of a different level of BNP, a chemical synthetic peptide, prepared in human EDTA plasma and preserved with sodium azide. The first level of BNP is set at a typical diagnostic cutoff level while the second and third are set at higher levels spanning the range of the test. The BNP value will be provided in the value assignment sheet for each level.
Calibration verification controls:
The i-STAT BNP Calibration Verification Control Set is packaged as a tri-level set comprised of two vials of each of three levels per box. The three levels in the BNP Calibration Verification Control Set are exactly the same materials as those used in the Level 1, Level 2, and Level 3 control products. The only difference between this product and the i-STAT BNP Controls is the number of vials and the number of levels that are packaged together.
2
Comparison to Technological Features of the Predicate Device:
The following is a comparison of technological features of the i-STAT and Biosite Triage BNP test methods:
| Characteristic | Triage BNP | I-STAT BNP |
|---|---|---|
| Assay methodology | Two-site ELISA | Two-site ELISA |
| Capture site | Heterogeneous | Heterogeneous |
| Capture antibodies | Monoclonal | Monoclonal |
| Enzyme label antibody | Monoclonal | Monoclonal |
| Enzyme label | Fluorescent dye | Alkaline phosphatase |
| Analysis sequence | Simultaneous capture/label | Simultaneous capture/label |
| Analysis time | 15 minutes | 10 minutes |
| Sample type | Whole blood or plasma | Whole blood or plasma |
| Enzyme detection | Fluorescent | Electrochemical |
The similarities and differences between the i-STAT controls products and the Biosite Triage BNP control products can be seen in the table below:
| Characteristics | Triage BNP Calibration
Verification Controls
(predicate device) | i-STAT BNP Control
Level 1, 2, & 3 and
i-STAT BNP Calibration
Verification Control Set
(new device) |
|--------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Matrix | Human Plasma | Human Plasma |
| Form | Frozen liquid | Frozen liquid |
| Analytes | BNP (assayed) | BNP (assayed) |
| Number of Levels | Three | Three |
| Differences | | |
| Opened Vial Claim | Tested same day as thaw | 4 hours when stored at 2 to 8°C |
| Vial | Plastic vial with screw top lid | 10 mL plastic vial with dropper-top |
| Fill volume | 0.5 ml | 1 ml |
| Storage (unopened) | ≤ -20°C
until expiration date | ≤ -18°C
until expiration date |
Summary of Performance in Support of Substantial Equivalence:
Test:
- Studies established that the i-STAT BNP test is insensitive to hematocrit levels from 0 to 60 . %PCV.
- . The i-STAT BNP assay is not significantly influenced by the presence of NT-pro-BNP, ANP or CNP at 1000 pg/mL or 20,000 pg/mL.
- Studies established that there are no significant interference effects on the i-STAT BNP test . from common medications, particularly those commonly prescribed to patients with cardiovascular conditions.
- . Studies established that the lower limit of detection (LLD) for the i-STAT method is 15 pg/mL versus 5.0 pg/mL for the Triage BNP test.
- . The imprecision of the i-STAT BNP test using plasma controls was established using in-house studies. The Level 1 Control %CV was 11.1% at 126 pg/mL; the Level 2 Control %CV was 8.1% at 1551 pg/mL, and the Level 3 Control %CV was 9.8% at 3337 pg/mL. This includes within-lot, lot-to-lot, vial-to-vial, analyzer-to-analyzer, and operator-to-operator components of the imprecision.
3
Studies conducted in-house compared the results of the i-STAT BNP test to those of the BNP test on the Abbott ARCHITECT. EDTA-anticoagulated samples were analyzed on both systems. The methods were compared using Deming regression analysis. The results are summarized in the table below:
| Statistic | Definition | i-STAT vs. Abbott ARCHITECT | |
|---|---|---|---|
| all samples | samples where | ||
| $[BNP]$ |