(270 days)
Roche Elecsys® 2010 immunoassay analyzer
No
The device description details a chromatographic immunoassay read by a reader that uses lot-specific calibration factors to convert band intensity to concentration. There is no mention of AI or ML in the description or performance studies.
No
The device is described as a rapid test for the in vitro quantitative determination of NT-proBNP as an aid in the diagnosis of CHF, not for the treatment or therapy of CHF.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use with the DXpress™ Reader to provide quantitative results as an aid in the diagnosis of CHF." This clearly indicates its role in the diagnostic process.
No
The device description clearly states that the StatusFirst™ CHF NT-proBNP test device is a physical test device utilizing immunoassay technology and is used in conjunction with the DXpress™ Reader, which is also a hardware component. This is not a software-only device.
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 device is for the "in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide (NT-proBNP) in human EDTA plasma." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The device analyzes "human EDTA plasma," which is a biological sample taken from a patient.
- Purpose: The test is used "as an aid in the diagnosis of CHF," indicating its role in providing diagnostic information.
- Device Description: The description details a laboratory-based immunoassay technology used to measure a substance in a biological sample.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
StatusFirstTM CHF (Congestive Heart Failure) NT-proBNP is a rapid test for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide (NT-proBNP) in human EDTA plasma. The device is intended for use with the DXpress™ Reader to provide quantitative results as an aid in the diagnosis of CHF.
Product codes
NBC
Device Description
The StatusFirst™ CHF NT-proBNP test device utilizes biotin coupled anti-NTproBNP antibody/streptavidin solid-phase chromatographic immunoassay technology to quantitatively determine the concentration of NT-proBNP in human EDTA plasma. After a sample has been dispensed into the sample well, the StatusFirst™ CHF NTproBNP test device is placed in the DXpress™ Reader. The DXpress™ Reader displays the NT-proBNP concentration 15 minutes after sample addition. The DXpress™ Reader is programmed to automatically convert the intensity of the test band (as indicated by the "pBNP" line on the test device) into a concentration of NTproBNP by using lot specific calibration factors supplied with each box of 20 StatusFirst™ CHF NT-proBNP test devices. The NT-proBNP concentration in the sample correlates with the intensity of the test band.
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
Not Found
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)
A method comparison was performed using a total of 355 CHF subjects and 333 non-CHF subjects. The non-CHF subjects include 282 apparently healthy subjects and 51 subjects with diabetes, renal insufficiency, hypertension or chronic obstructive pulmonary disease.
NT-proBNP levels from the above patient samples were measured with both the StatusFirst™ CHF NT-proBNP test in conjunction with the DXpress™ Reader, and the Roche Elecsys® proBNP immunoassay on the Roche Elecsys® 2010 immunoassay analyzer. Results within the measuring range of the StatusFirst™ CHF NT-proBNP test (20-5,000 pg/mL) were analyzed using Passing-Bablok regression.
a. CHF subjects: StatusFirst™ CHF NT-proBNP = 50.2 pg/mL+0.899* Elecsys® proBNP 95% confidence interval for intercept = [18.3, 74.0] 95% confidence interval for slope = [0.868, 0.939] Spearman Rank correlation was calculated as 0.922 with n = 324
b. Non-CHF subjects: StatusFirst™ CHF NT-proBNP = 5.0 pg/mL+1.022* Elecsys® proBNP 95% confidence interval for intercept = [0.3206, 9.4558] 95% confidence interval for slope = [0.9648, 1.0913] Spearman Rank correlation was calculated as 0.948 with n = 324
c. All subjects: StatusFirst™ CHF NT-proBNP = 9.4 pg/mL+0.956* Elecsys® proBNP 95% confidence interval for intercept = [5.1, 12.6] 95% confidence interval for slope = [0.934, 0.981] Spearman Rank correlation was calculated as 0.973 with n = 648
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision:
Within run
11.1%CV @ 64.9 pg/mL
12.8%CV @ 103.5 pg/mL
13.1%CV @ 375.5 pg/mL
16.8%CV @ 2145.8 pg/mL
Total
12.4%CV @ 64.9 pg/mL
13.7%CV @ 103.5 pg/mL
13.9%CV @ 375.5 pg/mL
18.1%CV @2145.8 pg/mL
Functional Sensitivity: 20 pg/mL
Limit of Detection: 20 pg/mL
Specificity: No substance demonstrated significant cross-reactivity (% cross-reactivity
§ 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.”
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MAR 1 3 2006
StatusFirst™ CHF NT-proBNP and DXpress™ Reader system 510(k) Premarket Submission K051596
Summary of Safety and Effectiveness of StatusFirst™ CHF NT-proBNP
This 510(k) summary of safety and effectiveness is submitted in accordance with the requirements of 21 CFR Sec. 807.92.
| Submitter's Name | Nanogen Inc. |
|---|---|
| Address | 10398 Pacific Center Court |
| San Diego, California 92121 | |
| Phone Number | 858-410-4877 |
| Contact Person | Van N. Schramm |
| Vice President, Regulatory Affairs and Quality | |
| Assurance | |
| Date of Original | |
| Preparation | June 13, 2005 |
| Date of Response to | |
| Request for Additional | |
| Information | March 6, 2006 |
| Device Names | Trade Name: StatusFirst™ CHF NT-proBNP |
| Common Name: Immunoassay for the quantitative | |
| determination of NT-proBNP in human EDTA plasma | |
| Classification Name: B-Type Natriuretic Peptide Test | |
| system (21 CFR 862.1117, product code NBC) | |
| Predicate Device | Roche's Elecsys® pro-BNP Immunoassay |
| K032646 | |
| Intended Use | StatusFirstTM CHF (Congestive Heart Failure) NT- |
| proBNP is a rapid test for the in vitro quantitative | |
| determination of N-terminal pro-Brain natriuretic peptide | |
| (NT-proBNP) in human EDTA plasma. The device is | |
| intended for use with the DXpress™ Reader to provide | |
| quantitative results as an aid in the diagnosis of CHF. |
1
Device Description
The StatusFirst™ CHF NT-proBNP test device utilizes biotin coupled anti-NTproBNP antibody/streptavidin solid-phase chromatographic immunoassay technology to quantitatively determine the concentration of NT-proBNP in human EDTA plasma. After a sample has been dispensed into the sample well, the StatusFirst™ CHF NTproBNP test device is placed in the DXpress™ Reader. The DXpress™ Reader displays the NT-proBNP concentration 15 minutes after sample addition. The DXpress™ Reader is programmed to automatically convert the intensity of the test band (as indicated by the "pBNP" line on the test device) into a concentration of NTproBNP by using lot specific calibration factors supplied with each box of 20 StatusFirst™ CHF NT-proBNP test devices. The NT-proBNP concentration in the sample correlates with the intensity of the test band.
Comparison to Predicate
A method comparison was performed using a total of 355 CHF subjects and 333 non-CHF subjects. The non-CHF subjects include 282 apparently healthy subjects and 51 subjects with diabetes, renal insufficiency, hypertension or chronic obstructive pulmonary disease.
NT-proBNP levels from the above patient samples were measured with both the StatusFirst™ CHF NT-proBNP test in conjunction with the DXpress™ Reader, and the Roche Elecsys® proBNP immunoassay on the Roche Elecsys® 2010 immunoassay analyzer. Results within the measuring range of the StatusFirst™ CHF NT-proBNP test (20-5,000 pg/mL) were analyzed using Passing-Bablok regression.
a. CHF subjects
StatusFirst™ CHF NT-proBNP = 50.2 pg/mL+0.899* Elecsys® proBNP 95% confidence interval for intercept = [18.3, 74.0] 95% confidence interval for slope = [0.868, 0.939] Spearman Rank correlation was calculated as 0.922 with n = 324
b. Non-CHF subjects
StatusFirst™ CHF NT-proBNP = 5.0 pg/mL+1.022* Elecsys® proBNP 95% confidence interval for intercept = [0.3206, 9.4558] 95% confidence interval for slope = [0.9648, 1.0913] Spearman Rank correlation was calculated as 0.948 with n = 324
2
c. All subjects
StatusFirst™ CHF NT-proBNP = 9.4 pg/mL+0.956* Elecsys® proBNP 95% confidence interval for intercept = [5.1, 12.6] 95% confidence interval for slope = [0.934, 0.981] Spearman Rank correlation was calculated as 0.973 with n = 648
The table below compares the StatusFirst™ CHF NT-proBNP test to the predicate device.
| Feature | StatusFirst™ CHF NT-proBNP | Elecsys® proBNP |
|---|---|---|
| 510(k) number | K051596 | K032646 |
| Intended Use | Immunoassay for the in vitro | |
| quantitative determination of N- | ||
| terminal pro-Brain natriuretic | ||
| peptide in human EDTA plasma | Immunoassay for the in vitro | |
| quantitative determination of N- | ||
| terminal pro-Brain natriuretic | ||
| peptide in human serum and | ||
| plasma | ||
| Indication for Use | StatusFirst™ CHF NT-proBNP is | |
| a rapid test used for the | ||
| quantitative determination of N- | ||
| terminal pro-Brain natriuretic | ||
| peptide (NT-proBNP) in human | ||
| EDTA plasma. | ||
| The device is intended to be used | ||
| with the DXpress™ Reader to | ||
| provide quantitative results as an | ||
| aid in the diagnosis of CHF. | Elecsys® proBNP is used as an aid | |
| in the diagnosis of individuals | ||
| suspected of having congestive | ||
| heart failure. | ||
| The test is further indicated for the | ||
| risk stratification of patients with | ||
| acute coronary syndrome and | ||
| congestive heart failure. | ||
| Assay Protocol (Type) | Chromatographic Immunoassay | Electrochemiluminescence |
| Immunoassay | ||
| Reference | Roche Elecsys® proBNP assay | Roche purified synthetic NT- |
| proBNP | ||
| Calibration Interval | Calibration of each specific lot is | |
| performed by the manufacturer | ||
| using clinical calibrators and | ||
| employing a 5-parameter logistic | ||
| curve fit. For each new lot, the | ||
| end-user needs only transfer | ||
| calibration information to the | ||
| reader(s) from the lot-specific data | ||
| chip provided. Once transferred (a | ||
| one-time only requirement), the | ||
| calibration information is good | ||
| until the expiration date of the | ||
| StatusFirst™ CHF NT-proBNP | ||
| test device. | E170/E2010 | |
| • After 1 month when using | ||
| the same reagent lot | ||
| • After 7 days when using | ||
| the same reagent kit |
E1010
• With every reagent kit
• After 7 days (20-25°C)
• After 3 days (25-32°C) |
| Feature | StatusFirst™ CHF NT-proBNP | Elecsys® proBNP |
| 510(k) number | K051596 | K032646 |
| Sample Type | Human EDTA plasma | Human serum and plasma |
| Reagent Stability | Unopened | Unopened |
| | Up to stated expiration
date when stored at 2-8°CStable for 14 days when
stored at 18-30°C,
provided the expiration
date printed on the pouch
is not exceeded | Up to stated expiration
date when stored at 2-8°COpened12 weeks at 2-8°C8 weeks on E1708 weeks on E20104 weeks on E1010 (20-
25°C ambient temp - up
to 20 hours opened in
total) |
| Calibrator | Electronic code chip | Elecsys® proBNP CalSet |
| Controls | Commercially available proBNP
controls | Elecsys® PreciControl proBNP |
| Result Interpretation (Cut-
off) | 125 pg/mL for patients younger
than 75 years and 450 pg/mL for
patients 75 years and older | 125 pg/mL for patients younger
than 75 years and 450 pg/ml for
patients 75 years and older |
| Instrument | DXpress™ Reader | Elecsys 1010, Elecsys 2010 and
MODULAR analytics E170 family
of analyzers |
| Measuring Range | 20-5,000 pg/mL | 5-35,000 pg/mL |
| Antibody | Monoclonal (mouse) antibody and
Polyclonal (goat) antibody | Polyclonal (sheep) antibody |
| Sample Volume | 3 drops using dropper provided
with test device | 20 µL |
| Precision | Within run
11.1%CV @ 64.9 pg/mL
12.8%CV @ 103.5 pg/mL
13.1%CV @ 375.5 pg/mL
16.8%CV @ 2145.8 pg/mL
Total
12.4%CV @ 64.9 pg/mL
13.7%CV @ 103.5 pg/mL
13.9%CV @ 375.5 pg/mL
18.1%CV @2145.8 pg/mL | E170 - Within run
0.9%CV @ 474 pg/mL
1.1%CV @ 8005 pg/mL
0.9%CV @ 13682 pg/mL
E170 - Total
5.8%CV @ 494 pg/mL
4.1%CV @ 7827 pg/mL
3.7%CV @13143 pg/mL
E1010/2010 - Within run
2.7%CV @ 175 pg/mL
2.4%CV @ 355pg/mL
1.9%CV @ 1068 pg/mL
1.8%CV @ 4962 pg/mL
E1010/2010 - Total
3.2%CV @175 pg/mL
2.9%CV @ 355 pg/mL
2.6%CV @ 1068 pg/mL
2.3%CV @ 4962 pg/mL |
| Hook Effect | No effect up to 300,000 pg/mL | No effect up to 300,000 pg/mL |
| Functional Sensitivity | 20 pg/mL | 5 mg/dL,
sample should not be taken
until 8 hours after
administration No interference from
rheumatoid factor up to 1500
IU/mL |
| | No interference with 63
commonly used
pharmaceuticals | Rare occurrence of
interference from high tiers of
anti-streptavidin and
ruthenium No interference with 51
commonly used
pharmaceuticals |
| | Use in conjunction with
patient medical history,
clinical exam and other
findings | Use in conjunction with
patient medical history,
clinical exam and other
findings |
Comparison to Predicate
3
4
5
StatusFirst™ CHF NT-proBNP 510(k) Premarket Submission K021296
Comments and conclusion on Substantial Equivalence
The StatusFirst™ CHF NT-proBNP and the Elecsys® proBNP assays are both intended for the in vitro quantitative determination of NT-proBNP. Both tests are indicated for use as an aid in the diagnosis of Congestive Heart Failure.
Good correlation has been demonstrated between the StatusFirst™ CHF NT-proBNP and the Elecsys® proBNP assays.
StatusFirst™ CHF NT-proBNP and the Elecsys® proBNP devices are substantially equivalent based upon their intended use and performance characteristics.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/6/Picture/2 description: The image shows a seal for the Department of Health & Human Services Utah. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES UTAH" around the perimeter. In the center of the seal is a stylized image of a person with their arms outstretched.
MAR 1 3 2006
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Van N. Schramm Vice President, Quality Assurance and Regulatory Affairs Nanogen, Inc. 10398 Pacific Center Court San Diego, CA 92121
Re: K051596
Trade/Device Name: StatusFirst™ CHF NT-proBNP Regulation Number: 21 CFR§862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class II Product Code: NBC Dated: February 17, 2006 Received: February 21, 2006
Dear Ms. Schramm:
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. Iisting 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
8
Indications for Use
510(k) Number (if known): K051596
Device Name: StatusFirst™ CHF NT-proBNP
Indications for Use: StatusFirst™ CHF (Congestive Heart Failure) NT-proBNP is a rapid test for the in-vitro quantitative determination of N-terminal pro-Brain natriuretic peptide (NT-proBNP) in human EDTA plasma. The device is intended for use with the DXpress™ Reader to provide quantitative results as an aid in the diagnosis of CHF.
Prescription Use
X
(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
Office of In Vitro Diagnos Device Evaluation and S
510(k) K051596
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