(191 days)
The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic (BNP) in human capillary whole blood, venous whole blood or plasma specimens using EDTA as the anticoagulant. The test is used as an aid in the diagnosis and assessment of scverity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes.
The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in human capillary whole blood, venous whole blood or plasma specimens using EDTA as the anticoagulant. The test is used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes.
Here's an analysis of the provided text regarding the Triage® B-Type Natriuretic Peptide (BNP) Test, structured according to your requested information:
1. Table of Acceptance Criteria and the Reported Device Performance
The provided text focuses on the equivalence of capillary whole blood samples to venous whole blood samples for the Triage® BNP Test, rather than specific diagnostic accuracy acceptance criteria (e.g., sensitivity, specificity, AUC). Therefore, the acceptance criteria are related to the comparability of these sample types.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Statistical Equivalence: No significant difference (p < 0.05) between results obtained from capillary whole blood and venous whole blood samples using the Wilcoxon Signed Ranks test. | Results obtained from capillary whole blood were not significantly different from results obtained using venous whole blood. |
| Correlation: Capillary whole blood results should correlate well with venous whole blood results. | Data were analyzed by linear regression (correlation mentioned, but specific coefficient not provided). |
| Robustness to Sample Collection: Equivalence should not be influenced by multiple finger sticks for capillary blood collection. | The correlation was not influenced by the number of fingersticks needed to collect enough sample to run the test. |
| Imprecision: Imprecision using whole blood should be comparable to imprecision using EDTA-anticoagulated plasma. | Imprecision studies indicated that the test imprecision using whole blood is comparable to the imprecision using EDTA-anticoagulated plasma. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for the Test Set: 67 paired samples (capillary whole blood and venous whole blood from the same individual).
- Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "comparison... from the same individual," implying a prospective collection of these paired samples. It's an in-house study by Biosite Incorporated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of study does not involve expert consensus for "ground truth" in the diagnostic sense. The "ground truth" here is the established method of testing (venous whole blood/plasma) to which the new sample type (capillary whole blood) is being compared. The determination of "ground truth" for the BNP measurement itself would have been established through a different, prior validation. No experts were used to establish ground truth for this specific comparison study. The comparison is against an existing, validated method.
4. Adjudication Method for the Test Set
Not applicable. This study compares two quantitative measurements from different sample types from the same individual. The results were "blinded," meaning the analysts did not know the sample source (capillary vs. venous) when performing the test and recording results, but there was no "adjudication" in the sense of resolving conflicting interpretations.
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
No. This is a study comparing different biological sample types for a quantitative biomarker test, not a reader study involving human interpretation of imaging or other complex data, nor does it involve AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way. The performance assessment is for the device (Triage® BNP Test) measuring BNP levels from different sample types. While human operators are involved in drawing blood and running the test, the performance itself is an analytical comparison of the device's output with different input matrices, rather than human interpretation. It's a standalone analytical performance evaluation.
7. The Type of Ground Truth Used
The "ground truth" for this specific study is the BNP measurement obtained from venous whole blood specimens, as this is the established or reference method against which the capillary whole blood specimens are being compared. The overall "ground truth" for BNP as a biomarker for heart failure would be clinical diagnosis and outcomes data, but that is not the focus of this particular study.
8. The Sample Size for the Training Set
Not explicitly stated or applicable for this type of analytical validation study. This study is an analytical comparison of sample types, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no machine learning "training set" in this context.
{0}------------------------------------------------
JAN 2 8 2004
Biosite Incorporated Triage® B-Type Natriuretic Peptide (BNP) Test
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | January 13, 2003 |
|---|---|
| Submitter: | Biosite Incorporated |
| Address: | 11030 Roselle StreetSan Diego, CA 92121Phone (858) 455-4808Fax (858) 535-8350 |
| Contact: | Jeffrey R. Dahlen, Ph.D.Clinical & Regulatory AffairsPrincipal Scientist |
| Device: | Trade/Proprietary Name:Triage® B-Type Natriuretic Peptide (BNP) Test |
| Common/Usual Name:BNP Test | |
| Classification: | Office of In Vitro Diagnostic Device Evaluation andSafety (OIVD)Panel - Clinical Chemistry and ToxicologyClassification Code - NBC |
| Predicate Devices: | Triage® B-Type Natriuretic Peptide (BNP) Test |
| Device Description and Intended Use: |
The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in human capillary whole blood, venous whole blood or plasma specimens using EDTA as the anticoagulant. The test is used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes.
{1}------------------------------------------------
Assessment of Performance:
A comparison between Triage® BNP Test results obtained from capillary whole blood specimens and venous whole blood specimens from the same individual was performed. A total of 67 paired samples were evaluated. All results were blinded.
43.3% of the capillary blood samples were obtained using a single finger stick, 35.8% of the samples were obtained using two finger sticks, and 20.9% of the samples were obtained using three or more finger sticks. Data were analyzed by linear regression and potential differences in the data sets were evaluated using the Wilcoxon Signed Ranks test, with p < 0.05 indicating a significant difference in the data sets. Analyses were performed based on the number of fingersticks required to obtain enough sample, and the entire data set was analyzed. The results of the analyses indicate that capillary whole blood is a suitable sample for use with the Triage® BNP Test and is equivalent to results obtained from venous whole blood. Results obtained from capillary whole blood were not significantly different from results obtained using venous whole blood. The correlation was not influenced by the number of fingersticks needed to collect enough sample to run the test.
Imprecision studies using whole blood samples spiked with purified BNP indicated that the test imprecision using whole blood is comparable to the imprecision using EDTA-anticoagulated plasma
The results of the study indicate that capillary whole blood is a suitable Conclusion: sample for use with the Triage® BNP Test and is equivalent to results obtained from venous whole blood.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 8 2004
Jeffrev R. Dahlen, Ph.D. Clinical & Regulatory Affairs Principal Scientist Biosite Incorporated 11030 Roselle Street San Diego, CA 92121
Re: K032235
Trade/Device Name: Triage® B-Type Natriuretic Peptide (BNP) Test Regulation Number: 21 CFR 862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC Dated: November 25, 2003 Received: November 26, 2003
Dear Dr. Dahlen:
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).
{3}------------------------------------------------
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours.
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Number (if known): K03 2235
Device Name:
Triage® B-Type Natriuretic Peptide (BNP) Test
Indications for Use:
The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic (BNP) in human capillary whole blood, venous whole blood or plasma specimens using EDTA as the anticoagulant. The test is used as an aid in the diagnosis and assessment of scverity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C. Benson for Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032235
Prescription Use (Per 21CFR 801.109) OR
Over-The-Counter Use
§ 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.”