(417 days)
Not Found
No
The description focuses on the chemical reagents and the immunoassay system, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic device used to measure cardiac troponin I levels to aid in the diagnosis of myocardial infarction, not to treat a condition.
Yes.
The Access 2 Immunoassay System is explicitly stated to be an "in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids." Additionally, the reagent and calibrators are intended "to aid in the diagnosis of myocardial infarction."
No
The device description explicitly details reagents, calibrators, and an immunoassay system, which are all hardware and chemical components, not software.
Based on the provided text, the device is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated in Intended Use/Indications for Use: The text clearly states: "The Access 2 Immunoassay System is an in vitro diagnostic device..." and "The Access AccuTnl+3 reagents, AccuTnl+3 calibrators and the Access 2 Immunoassay System compose the Access Immunoassay System for the quantitative determination of cardiac troponin I (cTn!) in human serum and plasma."
- Explicitly Stated in Device Description: The text reiterates: "The Access 2 Immunoassay System is an in vitro diagnostic device..." and "The Access AccuTnI+3 reagent packs contain specific reagents for the in vitro diagnostic measurement of cTnI..."
- Analyzes Human Body Fluids: The intended use and device description specify that the system is used for determining analyte concentrations in "human serum and plasma," which are human body fluids.
- Aids in Diagnosis: The intended use states that the assay is used "to aid in the diagnosis of myocardial infarction." This is a key characteristic of an IVD.
Therefore, the Access AccuTnl+3 Reagent, Access AccuTnl+3 Calibrators, and the Access 2 Immunoassay System, as described, collectively function as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access AccuTnI+3 Reagent is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction.
The Access AccuTnI+3 Calibrators are intended to calibrate the Access AccuTnI+3 Reagent for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction.
The Access 2 Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Product codes (comma separated list FDA assigned to the subject device)
MMI, JIT, JJE
Device Description
The Access AccuTnI+3 reagents, AccuTnI+3 calibrators and the Access 2 Immunoassay System compose the Access Immunoassay System for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma.
The Access AccuTnI+3 reagent packs contain specific reagents for the in vitro diagnostic measurement of cTnI including:
- Paramagnetic particles coated with mouse monoclonal anti-human cardiac . troponin I suspended in TRIS buffered saline, with surfactant, bovine serum albumin (BSA) matrix.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.
0
510(k) Summary
JUN 1 4 2013
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92
The assigned 510(k) number is K121214
Submitted By:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-1142 Fax: (952) 368-7610
Contact Person:
Kerrie Oetter 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-7858 Fax: (952) 368-7610
Date Prepared:
June 12, 2013
Device Name:
Proprietary / Trade Name: Access AccuTn1+3 Reagent for use on the Access 2 Immunoassay Systems Common Name: Troponin I Enzyme Immunoassay Classification Name: Immunoassay, Troponin Subunits Classification Regulation: 21 CFR 862.1215 Classification Product Code: MMI
Proprietary / Trade Name: Access AccuTnI+3 Calibrator Common Name: Calibrator Classification Name: Calibrator Classification Regulation: 21 CFR 862.1150 Subsequent Product Code: JIT
Proprietary / Trade Name: Access 2 Immunoassay System Common Name: Discrete photometric chemistry analyzer for clinical use Classification Name: Discrete photometric chemistry analyzer for clinical use Classification Regulation: 21 CFR 862.2160 Classification Product Code: JJE
1
Predicate Devices:
The Access AccuTnl+3 Reagent and AccuTnl+3 Calibrators claim substantial equivalence to the ADVIA Centaur TnI-Ultra™ Assay and ADVIA Centaur TnI-Ultra™ Calibrators for the Siemens ADVIA Centaur® System. FDA 510(k) Number K053020, cleared December 30, 2005.
The Access 2 Immunoassay System claims substantial equivalence to the Access 2 Immunoassay System (K922823/A007), cleared July 2, 2001.
Device Description:
The Access AccuTnl+3 reagents, AccuTnl+3 calibrators and the Access 2 Immunoassay System compose the Access Immunoassay System for the quantitative determination of cardiac troponin I (cTn!) in human serum and plasma.
The Access AccuTnI+3 reagent packs contain specific reagents for the in vitro diagnostic measurement of cTnI including:
- Paramagnetic particles coated with mouse monoclonal anti-human cardiac . troponin I suspended in TRIS buffered saline, with surfactant, bovine serum albumin (BSA) matrix. in vitro diagnostic method for the
quantitative measurement of cardiac
TnI in serum and plasma to aid in the
diagnosis of myocardial infarction. | same |
| Assay Principle | Chemiluminescent sandwich
immunoassay | same |
| Test System | Automated immunoassay instrument | same |
| Sample Type | Serum and heparinized plasma | same |
| Reagent Pack
configuration | Reagents ready to use and separated in
a single reagent pack | same |
| Primary Reagent
Materials | Solid phase magnetic particles, anti-
cTnI antibodies | same |
Differences between the Access AccuTnI+3 Reagent and Calibrator and the Predicate
| Characteristic | Predicate Device
ADVIA Centaur® TnI-Ultra™
K053020 | New Device
Access AccuTnl+3 Reagent and Access
AccuTnl+3 Calibrators |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample Type | EDTA plasma | No EDTA plasma claim |
| Immunoassay
Instrument | ADVIA Centaur | Access 2 Immunoassay System |
| Calibrator
Materials | Bovine cTnI in goat serum | Recombinant troponin complex in buffered
BSA |
| Calibrators:
number and type | Two Lyophilized : high and low (use
with Master Curve) | Six Liquid: approximately 0, 0.3, 1.2, 5.0,
25 and 100 ng/mL with no master curve |
| | Predicate Device | New Device |
| Characteristic | ADVIA Centaur® Tnl-Ultra™
K053020 | Access AccuTnI+3 Reagent and Access
AccuTnI+3 Calibrators |
| Specific Reagent
Materials | Polyclonal goat anti-cTnI antibody
labeled with acridinium ester, 2
biotinylated mouse monoclonal anti-
cTnI antibodies, magnetic particles
conjugated with streptavidin | Mouse monoclonal anti-human cTnI
alkaline phosphatase conjugate, magnetic
particles coated with mouse monoclonal
anti-human cTnI |
| Sample Volume | 100μl | 55μl |
| Analytical
Measuring Range | 0.008 ng/mL to 50 ng/mL | 0.02 ng/mL to 100 ng/mL |
| Acute Myocardial
Infarction (AMI)
Cutoff | 0.9 ng/mL per WHO-defined cutoff | 0.03ng/mL based on clinical trial outcome |
| Expected Results
(Upper Reference
Limit) | 99th percentile of 0.04 ng/mL; range of
0.02- 0.06 ng/mL | 99th percentile of 0.02 with a 95%
Confidence Interval (CI) of 0.01- 0.05
ng/mL |
| Precision | Total CV of 10% at a level of 0.042
ng/mL | Total CV of ≤8% at concentrations >0.075
ng/mL. SD ≤0.006 at concentrations
≤0.075 ng/mL |
| Indications for
Use Statement | The ADVIA Centaur® Tnl-Ultra (Tnl
Ultra) is for in vitro diagnostic use-in
the quantitative determination of
cardiac Troponin in human serum and
heparinized and EDTA plasma.
Cardiac troponin I determinations aid
in the diagnosis of acute myocardial
infarction and in the risk stratification
of patients with non-ST segment
elevation acute coronary syndromes
with respective to relative risk
mortality, myocardial infarction or
increased probability of ischemic
events requiring urgent
revascularization procedures.
The ADVIA Centaur® TnI-Ultra
Calibrator is for the in-vitro diagnostic
use in the calibration of the TnI-Ultra
assay on the ADVIA Centaur®
System. | The Access AccuTnI+3 assay is a
paramagnetic particle, chemiluminescent
immunoassay for the quantitative
determination of cardiac troponin I (cTnI)
levels in human serum and plasma using
the Access 2 Immunoassay System to aid
in the diagnosis of myocardial infarction.
The Access AccuTnI+3 Calibrators are
intended to calibrate the Access
AccuTnI+3 assay for the quantitative
determination of cardiac troponin I (cTnI)
levels in human serum and plasma using
the Access 2 Immunoassay System to aid
in the diagnosis of myocardial infarction. |
3
The Access 2 Immunoassay System and the previously cleared version of the Access 2 Immunoassay System were compared.
.
:
:
:
·
.
.
.
・
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:
.
.
..... .
4
| Characteristic | Predicate Device
Access 2 System
K922823/A007 | New Device
Access 2 Immunoassay System |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Indication for Use | The Access 2 Immunoassay system is
an in vitro diagnostic device used for
the quantitative, semi-quantitative, or
qualitative determination of various
analyte concentrations found in human
body fluids. | same |
| Operating
Principle | Micro computer controlled, random
and continuous access | same |
| Assay Type | Enzyme immunoassays | same |
| Detection | Chemiluminescent | same |
| Modules | Carousel, pipettor, analytical, fluidic,
electronic/systems computer/peripheral | same |
Similarities between the Access 2 Immunoassay System and the Predicate
Differences between the Access 2 Immunoassay System and the Predicate
| Characteristic | Predicate Device
Access 2 Immunoassay System
K922823/A007 | New Device
Access 2 Immunoassay System |
|---------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Thermal algorithm
capability | Not present | Present |
| Assay Protocol
File (APF) | AccuTnl APF | AccuTnl APF with addition of the thermal
algorithm and "U" command |
| Software | Version 2.4-3.2 | Version 3.3: added capability to implement
the thermal algorithm and "U" Command;
added result suppression when instrument
internal case temperature is outside 18° to
36°C |
| Operating
Temperature | 18°C to 32°C ambient | 18°C to 28°C ambient
18°C to 36°C |
Conclusion: The information provided above demonstrates that the new device, the Access AccuTnI+3 Reagent and Access AccuTnI+3 Calibrators, have the same intended use as the predicate device. The Access 2 instrument has the same intended use as the predicate device. In addition, verification and validation testing, the clinical and analytical data, the clinical use of the product reflected in current MI diagnostic guidelines, and other scientific information provided in this submission demonstrate that the Access AccuTnI+3 Reagent, Access AccuTnI+3 Calibrators on the Access 2 Immunoassay Systems is as safe and effective as the predicate devices. Taken together, this information establishes the substantial equivalence of Beckman Coulter's products to predicates.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2013
Beckman Coulter, Inc. C/O Kerrie Oetter 1000 Lake Hazeltine Drive CHASKA MN 55318-1084
Re: K121214
Trade/Device Name: Access AccuTnl+3 Reagent and Access AccuTnl+3 Calibrators for use on the Access 2 Immunoassay Systems
Regulation Number: 21 CFR 862.1215
· Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: II Product Code: MMI, JIT, JJE Dated: June 04, 2013 Received: June 06, 2013
Dear Ms. Oetter:
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 .- Please note: - GDRH-does not-evaluate-information-related-to-contract-liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2-Ms. Oetter
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Courtney Hillias, Ph.D.
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use Form
510(k) Number (if known): K121214
Device Name: Access AccuTnl+3 Reagent and Access AccuTnl+3 Calibrators for use on the Access 2 Immunoassay Systems
Indications for Use:
The Access AccuTnl+3 Reagent is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction.
The Access AccuTnl+3 Calibrators are intended to calibrate the Access AccuTnl+3 Reagent for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction.
The Access 2 Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Prescription Use x Prescription Use _____________________________________________________________________________________________________________________________________________________________
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 Diagnostics and Radiological Health (OIR)
Ruth A. Chešler/S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K121214 510(k)