(166 days)
Not Found
No
The device description and intended use focus on a standard immunoassay technology and its associated reagents and controls. There is no mention of AI, ML, or any computational methods that would suggest their use in the analysis or interpretation of results beyond standard calibration and curve fitting.
No
The device is an immunoassay used for in vitro quantitative determination of analytes to aid in diagnosis and risk stratification, not to treat or alleviate a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Elecsys proBNP II assay is "used as an aid in the diagnosis of individuals suspected of having congestive heart failure." This directly indicates its role in diagnosis.
No
The device description clearly outlines physical components (reagents, calibrators, quality control materials) and their use with specific hardware (Elecsys and cobas e immunoassay analyzers). This is an in vitro diagnostic device with physical components, 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 "Immunoassay for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Sample Type: The test is performed on "human serum and plasma," which are biological samples taken from the body but tested outside of it.
- Purpose: The test is used as an "aid in the diagnosis," "risk stratification," and "aid in the assessment of increased risk of cardiovascular events and mortality," all of which are diagnostic purposes.
- Device Description: The description details an "immunoassay" and the components used to perform the test on biological samples.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Elecsys proBNP II: Immunoassay for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide in human serum and plasma. Elecsys proBNP II assay 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. The test may also serve as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
The Elecsys PreciControl Cardiac II is used for quality control of specified immunoassays on the Elecsys and cobas e immunoassay analyzers.
The Elecsys proBNP II CalSet is used for calibrating the quantitative Elecsys proBNP II assay on the Elecsys and cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
NBC, JJY, JIT
Device Description
1.) The Elecsys proBNP II Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
2.) The Elecsys PreciControl Cardiac II is a lyophilized product consisting of human serum with added CK-MB, Digitoxin (not for use in U.S), Digoxin, Myoglobin, and NT-proBNP 1-76 in two concentration ranges. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
3.) The Elecsys proBNP II CalSet is a lyophilized product consisting of equine serum with added NT-proBNP 1-76 in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Note: The reagent, calibrator, and quality control material are all packaged separately.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
K672437
510(k) Summary
FEB - 5 2008
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. | | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Road
Indianapolis, IN 46250
(317) 521-3544 | | |
| | Contact Person: Kay Taylor | | |
| | Date Prepared: January 28, 2008 | | |
| Device Name | Proprietary name: 1.) Elecsys® proBNP II Immunoassay
2.) Elecsys® PreciControl Cardiac II
3.) Elecsys® proBNP II CalSet
Common name:
1.) proBNP Assay
2.) PreciControl Cardiac
1.) proBNP CalSet
Classification name: 1.) Test, Natriuretic Peptide
2.) Multi-Analyte Controls, All Kinds (Assayed and
Unassayed)
3.) Calibrator, Secondary | | |
1
| Description | 1.) The Elecsys proBNP II Assay is a two step sandwich immunoassay with
streptavidin microparticles and electrochemiluminescence detection.
Results are determined using a calibration curve that is generated
specifically on each instrument by a 2 point calibration and a master curve
provided with the reagent bar code.
2.) The Elecsys PreciControl Cardiac II is a lyophilized product consisting of
human serum with added CK-MB, Digitoxin (not for use in U.S),
Digoxin, Myoglobin, and NT-proBNP 1-76 in two concentration ranges.
During manufacture, the analytes are spiked into the matrix at the desired
concentration levels.
3.) The Elecsys proBNP II CalSet is a lyophilized product consisting of
equine serum with added NT-proBNP 1-76 in two concentration ranges.
During manufacture, the analyte is spiked into the matrix at the desired
concentration levels.
Note: The reagent, calibrator, and quality control material are all packaged
separately. |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for
Use | Elecsys proBNP II: Immunoassay for the in vitro quantitative determination
of N-terminal pro-Brain natriuretic peptide in human serum and plasma.
Elecsys proBNP II assay 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. The test may also serve as an aid in the assessment of increased
risk of cardiovascular events and mortality in patients at risk for heart failure
who have stable coronary artery disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on
Elecsys and cobas e immunoassay analyzers.
The Elecsys PreciControl Cardiac II is used for quality control of specified
immunoassays on the Elecsys and cobas e immunoassay analyzers.
The Elecsys proBNP II CalSet is used for calibrating the quantitative
Elecsys proBNP II assay on the Elecsys and cobas e immunoassay analyzers. |
2
| Substantial
equivalence | The Elecsys proBNP II Test System is substantially equivalent to other
devices legally marketed in the United States.
1.) Elecsys proBNP II Immunoassay is equivalent to the Elecsys proBNP
Immunoassay (K051382). |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2.) Elecsys PreciControl Cardiac II is equivalent to Elecsys PreciControl
Cardiac (K032089).
3.) Elecsys proBNP II CalSet is equivalent to Elecsys proBNP CalSet
(K022516). |
| Device | The following table compares the Elecsys proBNP II test system with the |
|---|---|
| Comparison - | predicate device (K051382). |
| Immunoassay |
| Immunoassay | ||
|---|---|---|
| Feature | Elecsys proBNP II Assay | Elecsys proBNP Assay |
| (K051382)Predicate | ||
| Intended Use / | ||
| Indication for Use | Immunoassay for the in vitro | |
| quantitative determination of N- | ||
| terminal pro-Brain □atriuretic | ||
| peptide in human serum and | ||
| plasma. The Elecsys proBNP assay | ||
| 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. The test may also | ||
| serve as an aid in the assessment of | ||
| increased risk of cardiovascular | ||
| events and mortality in patients at | ||
| risk for heart failure who have | ||
| stable coronary artery disease. |
The electrochemiluminescence
immunoassay “ECLIA” is intended
for use on Elecsys and cobas e
immunoassay analyzers. | Same
The electrochemiluminescence
immunoassay “ECLIA” is intended
for use on the Elecsys 1010/2010
and MODULAR ANALYTICS
E170 (Elecsys module)
immunoassay analyzers. |
| | Immunoassay | |
| Feature | Elecsys proBNP II Assay | Elecsys proBNP Assay
(K051382)Predicate |
| Analyzer Platforms | Elecsys 1010
Elecsys 2010 / cobas e 411
MODULAR ANALYTICS E170
(Elecsys module) / cobas e 601 | Elecsys 1010
Elecsys 2010
MODULAR ANALYTICS E170
(Elecsys module) |
| Assay Protocol | Sandwich Principle | Same |
| Detection Protocol | Electrochemiluminescent | Same |
| Traceability /
Standardization | Standardized against the Elecsys
proBNP assay. | Reference standard - purified
synthetic NT-proBNP (1-76) in
equine serum matrix |
| Calibration Interval | E170/E2010/ cobas e analyzers
• 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) | E170/E2010
• After 1 month (28 days) 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) |
| Sample Type | Human serum and plasma | Same |
| Reagent Stability | Unopened
• Up to stated expiration date
stored at 2-8°C
Opened
• 12 weeks at 2-8°
• 8 weeks on E170/cobas e
601
• 8 weeks on E2010/ cobas e
411
• 4 weeks on E1010 (20-25°
ambient temp, up to 20
hours opened in total) | Unopened
• Up to stated expiration date
stored at 2-8°C
Opened
• 12 weeks at 2-8°
• 8 weeks on E170
• 8 weeks on E2010
• 4 weeks on E1010 (20-25°
ambient temp, up to 20
hours opened in total) |
| Calibrator | Elecsys proBNP II CalSet | Elecsys proBNP CalSet |
| Controls | Elecsys PreciControl Cardiac II | Elecsys PreciControl Cardiac |
| Result Interpretation | 125 pg/ml for patients younger than
75 years and 450 pg/ml for patients
75 years and older | Same |
| Feature | Elecsys proBNP II Assay | Elecsys proBNP Assay
(K051382)Predicate |
| Instrument | Elecsys 1010, Elecsys 2010, cobas
e 411, cobas e 601, and
MODULAR analytics E170 family
of analyzers | Elecsys 1010
Elecsys 2010
MODULAR ANALYTICS E170
(Elecsys module) |
| Measuring Range | 5-35,000 pg/mL | Same |
| Precision | E170 and cobas e601 – Within run | E170 - Within run |
| | 1.9% CV @ 64 pg/mL | 0.9% CV @ 474 pg/mL |
| | 1.5% CV @ 124 pg/mL | 1.1% CV @ 8005 pg/mL |
| | 1.3% CV @ 14142 pg/mL | 0.9% CV @ 13682 pg/mL |
| | 1.8% CV @ 77.0 pg/mL | 0.8% CV @ 208 pg/mL |
| | 1.2% CV @ 2105 pg/mL | 3.0% CV @ 3786 pg/mL |
| | E170 and cobas e601 - Total | E170 - Total |
| | 3.1% CV @ 46 pg/mL | 5.8% CV @ 494 pg/mL |
| | 2.7% CV @ 125 pg/mL | 4.1% CV @ 7827 pg/mL |
| | 1.7% CV @ 32930 pg/mL | 3.7% CV @ 13143 pg/mL |
| | 2.7% CV @ 77.0 pg/mL | 4.5% CV @ 200 pg/mL |
| | 2.7% CV @ 2170 pg/mL | 3.6% CV @ 4002 pg/mL |
| | E1010/2010 and cobas e 411 –
Within run | E1010/2010 - Within run |
| | 4.2%CV @ 44.0 pg/mL | 2.7% CV @ 175 pg/mL |
| | 2.4%CV @ 126 pg/mL | 2.4% CV @ 355 pg/mL |
| | 1.3%CV @ 2410 pg/mL | 1.9% CV @ 1068 pg/mL |
| | 2.7%CV @ 33606 pg/mL | 1.8% CV @ 4962 pg/mL |
| | 2.58% CV @ 82.0 pg/mL | 1.8% CV @ 434 pg/mL |
| | 1.18% CV @ 2318 pg/mL | 1.8% CV @ 6781 pg/mL |
| | | |
| | E1010/2010 and cobas e411 –
Total | E1010/2010 - Total |
| | 4.6%CV @ 44.0 pg/mL | 3.2% CV @ 175 pg/mL |
| | 2.6%CV @ 126 pg/mL | 2.9% CV @ 355 pg/mL |
| | 1.8%CV @ 2410 pg/mL | 2.6% CV @ 1068 pg/mL |
| | 3.8%CV @ 33606 pg/mL | 2.3% CV @ 4962 pg/mL |
| | 2.8% CV @ 82.0 pg/mL | 2.4% CV @ 434 pg/mL |
| | 1.6% CV @ 2318 pg/mL | 2.2% CV @ 6781 pg/mL |
| | | |
| Immunoassay, continued | | |
| Feature | Elecsys proBNP II Assay | Elecsys proBNP Assay
(K051382)Predicate |
| Hook Effect | No effect up to 300,000 pg/mL | same |
| Analytical Sensitivity | 5 pg/mL | same |
| Method Comparison | Elecsys proBNP II (y) compared to
Elecsys proBNP (x): linear
regression (y= 1.0x – 21.74);
Passing/Bablok (y= 0.98x – 0.31) | n.a. |
| Limit of Blank /
Analytical Sensitivity | 1.72 pg/mL | 5 pg/mL |
| Limit of Detection | 2.83 pg/mL | |
| Limit of Quantitation
(as determined by a
functional sensitivity
study) | 50 pg/mL | 5 mg/day, sample should not be taken until 8 hours after administration. Rare occurrence of interference from high titers of anti-streptavidin and ruthenium Use in conjunction with patient medical history, clinical exam and other findings | No interference from bilirubin if less than 35 mg/dL No interference from hemoglobin if less than 1.4 g/dL No interference from triglycerides if less than 4000 mg/dL No interference with biotin if less than 30 ng/mL No interference from rheumatoid factor up to 1500 IU/mL In patients receiving high biotin doses > 5 mg/day, sample should not be taken until 8 hours after administration. Rare occurrence of interference from high titers of anti-streptavidin and ruthenium Use in conjunction with patient medical history, clinical exam and other findings |
.
3
·
4
5
:
6
Device The following table compares the Elecsys proBNP II test system with the Comparison predicate device (K032089). PreciControl Cardiac II
| PreciControl Comparison | ||
|---|---|---|
| Characteristic | Elecsys PreciControl Cardiac II | Elecsys PreciControl Cardiac |
| (K032089) Predicate | ||
| Intended Use | Used for quality control of | |
| specified immunoassays on the | ||
| Elecsys and cobas e immunoassay | ||
| analyzers. | Used for quality control of the | |
| Elecsys CK-MB, Digoxin, | ||
| Myoglobin, and NT-proBNP | ||
| immunoassays on the Elecsys | ||
| immunoassay systems. | ||
| Levels | Two | same |
| Format | Lyophilized, based on human | |
| serum | same | |
| Analyte Concentration | CK-MB: approx. 5 and 50 ng/ml | |
| Digitoxin: approx. 17 and 38 | ||
| ng/mL (not for use in U.S.) | ||
| Digoxin: approx. 1.2 and 3 ng/ml | ||
| Myoglobin: approx. 80 and 1000 | ||
| ng/ml | ||
| NT-proBNP: approx. 0.15 and 5 | ||
| ng/ml | CK-MB: approx. 5 and 50 ng/ml | |
| Digoxin: approx. 1.2 and 3 ng/ml | ||
| Myoglobin: approx. 80 and 1000 | ||
| ng/ml | ||
| NT-proBNP: approx. 0.15 and 5 | ||
| ng/ml | ||
| Stability | Unopened: store at 2 - 8°C up to | |
| expiration date |
Reconstituted:
3 hrs at 20 - 25°C (on analyzer)
3 days at 2 - 8°C
3 months at -20°C (freeze only
once)
After thawing -- use only once | same |
| Handling | Dissolve carefully the contents of
one bottle by adding exactly 2.0
mL of distilled water and allow
stand closed for 15 minutes to
reconstitute. Mix carefully,
avoiding the formation of foam. | same |
7
Device The following table compares the Elecsys proBNP II test system with the Comparison predicate device (K032089). CalSet
| CalSet Comparison | ||
|---|---|---|
| Characteristic | Elecsys proBNP II CalSet | Elecsys proBNP CalSet |
| (K022516) Predicate | ||
| Intended Use | Used for calibrating the | |
| quantitative Elecsys proBNP II | ||
| assay on Elecsys and cobas e | ||
| immunoassay analyzers. | Used for calibrating the | |
| quantitative Elecsys proBNP assay | ||
| on Elecsys 1010/2010 and | ||
| MODULAR ANALYTICS E170 | ||
| immunoassay systems. | ||
| Levels | Two | same |
| Format | Lyophilized, based on equine | |
| serum | same | |
| Stability | Unopened: | |
| • Store at 2 - 8°C until expiration | ||
| date. | ||
| Reconstituted: | ||
| • 2 – 8°C: 2 weeks | ||
| • -20°C: 3 months (freeze only | ||
| once) | ||
| • On Elecsys 1010/2010 and | ||
| cobas e411 analyzers at 20 - | ||
| 25°C: up to 5 hours | ||
| • On MODULAR ANALYTICS | ||
| E170 and cobas e601 | ||
| analyzers: use only once | Unopened: | |
| • Store at 2 - 8°C until expiration | ||
| date. | ||
| Reconstituted: | ||
| • 2-8°C: 2 weeks | ||
| • -20°C: 3 months (freeze only | ||
| once) | ||
| • On Elecsys 1010/2010 | ||
| analyzers at 20 - 25°C: up to 5 | ||
| hours | ||
| • On MODULAR ANALYTICS | ||
| E170: use only once | ||
| Handling | Dissolve contents of one bottle by | |
| adding exactly 1.0 mL of distilled | ||
| water and allow to stand closed for | ||
| 15 minutes to reconstitute. Mix | ||
| carefully, avoiding the formation of | ||
| foam. | same |
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
FEB - 5 2008
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Inc. c/o Ms. Kay A. Taylor MT (ASCP) Regulatory Affairs Principal 9115 Hague Road PO Box 50457 Indianapolis, IN 46250
K072437 Re:
Trade/Device Name: Elecsys proBNP II Immunoassay Regulation Number: 21 CFR§ 862.1117 Regulation Name: B-Type Natriuretic Peptide Regulatory Class: Class II Product Code: NBC, JJY, JIT Dated: January 29, 2008 Received: January 30, 2008
Dear Ms. Taylor:
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).
9
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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., 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
10
Indications for Use - Elecsys proBNP II Immunoassay
510(k) Number (if known):
Device Name: Elecsys proBNP II Immunoassay
Indication For Use:
Immunoassay for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide in human serum and plasma. Elecsys proBNP II assay 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. The test may also serve as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Prescription Use XXX (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072437
Page 1 of 3
11
Indication for Use – Elecsys PreciControl Cardiac II
510(k) Number (if known):
Device Name: Elecsys PreciControl Cardiac II
Indication For Use:
The Elecsys PreciControl Cardiac II is used for quality control of specified immunoassays on the Elecsys and cobas e immunoassay analyzers.
Prescription Use XXX (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benenn
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072437
Page 3 of 3
12
Indication for Use - Elecsys proBNP II CalSet
510(k) Number (if known):
Device Name: Elecsys proBNP II CalSet
Indication For Use:
The Elecsys proBNP II CalSet is used for calibrating the quantitative Elecsys proBNP II assay on the Elecsys and cobas e immunoassay analyzers.
Prescription Use XXX (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072437
Page 2 of 3