(464 days)
Not Found
No
The description focuses on the reagents, calibrators, and the immunoassay system hardware, which performs standard quantitative measurements. There is no mention of AI or ML in the intended use, device description, or any of the provided sections.
No
The device is described as an "in vitro diagnostic device" used for quantitative determination of cardiac troponin I levels, which aids in diagnosis and does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used to "aid in the diagnosis of myocardial infarction" and that the "UniCel DxI 800 Access Immunoassay System is an in vitro diagnostic device".
No
The device description explicitly details physical components including reagents, calibrators, and an immunoassay system, none of which are software-only.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The text explicitly states: "The UniCel DxI 800 Access 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." This is a direct declaration of its IVD status.
- Intended Use: The intended use clearly describes the device's purpose: "for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma... to aid in the diagnosis of myocardial infarction." This involves testing human body fluids (serum and plasma) outside of the body to provide information for a medical diagnosis, which is the core definition of an IVD.
- Device Description: The description details the components (reagents, calibrators, and the system) used for this in vitro measurement of cTnI in human samples.
- Predicate Devices: The listed predicate devices (K053020 and K023764) are also described as IVD devices, further supporting the classification of this device as an IVD.
Therefore, all aspects of the provided text point to this device being an In Vitro Diagnostic.
N/A
Intended Use / 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 UniCel Dxl Access Immunoassay Systems 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 1 (cTnl) levels in human serum and plasma using the UniCel Dxl Access Immunoassay Systems to aid in the diagnosis of myocardial infarction.
The UniCel Dxl 800 Access 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, AccuTn1+3 Calibrators and the UniCel Dx1 800 Access Immunoassay System compose the Access Immunoassay System for the quantitative determination of cardiac troponin I (cTnl) in human serum and plasma.
The Access AccuTnl+3 Reagent packs contain specific reagents for the in virro diagnostic measurement of cTnl including:
- · Paramagnetic particles coated with mouse monoclonal anti-human cardiac troponin I (cTnl) suspended in TRIS buffered saline, with surfactant, bovine serum albumin (BSA) matrix. 0.075 ng/mL. SD ≤0.006 at concentrations ≤0.075 ng/mL
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
§ 862.1215 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
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 K121790
Submitted By:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-1142 Fax: (952) 368-7610
Contact Person:
Kerrie Oetter Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-7858 Fax: (952) 368-7610
Date Prepared:
September 23, 2013
Device Name:
Proprietary / Trade Name: Access AccuTnl+3 Reagent for use on the UniCel DxI Access Immunoassay Systems Common Name: Troponin I Enzyme Immunoassay Classification Name: Immunoassay, Troponin Subunits Classification Regulation: 21 CFR 862.1215 Product Code: MMI
Proprietary / Trade Name: Access AccuTnl+3 Calibrator Common Name: Calibrator Classification Name: Calibrator Classification Regulation: 21 CFR 862.1150 Product Code: JIT
Proprietary / Trade Name: UniCel Dx1 800 Access 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 Product Code: JJE
SEP 2 5 2013
1
Predicate Device:
The Access AccuTnI+3 Reagent and AccuTnI+3 Calibrators for use on the UniCel DxI Access Immunoassay Systems claim substantial equivalence to the TnI-Ultra™ Assay and ADVIA Centaur TnlUitra Calibrators for the Siemens ADVIA Centaur® System. FDA 510(k) Number K053020, cleared December 30, 2005.
The UniCel Dx1 800 Access Immunoassay System claims substantial equivalence to the UniCel DxI 800 Access Immunoassay System (K023764), cleared January 28, 2003.
Device Description:
The Access AccuTnI+3 Reagents, AccuTn1+3 Calibrators and the UniCel Dx1 800 Access Immunoassay System compose the Access Immunoassay System for the quantitative determination of cardiac troponin I (cTnl) in human serum and plasma.
The Access AccuTnl+3 Reagent packs contain specific reagents for the in virro diagnostic measurement of cTnl including:
- · Paramagnetic particles coated with mouse monoclonal anti-human cardiac troponin I (cTnl) 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 |
Similarities between the Access AccuTn1+3 Reagent and Calibrator and the Predicate
Differences between the Access AccuTn1+3 Reagent and Calibrator and the Predicate
| Characteristic | Predicate Device
ADVIA Centaur® TnI-Ultra™
K053020 | New Device
Access AccuTnl+3 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Sample Type | EDTA plasma | No EDTA plasma claim |
| Immunoassay
Instrument | ADVIA Centaur | UniCel Dxl 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: 0 and approximately 0.2, 0.9,
3.7, 20 and 80 ng/mL with no master curve |
| Specific
Reagent
Materials | Polyclonal goat anti-cTnl antibody labeled
with acridinium ester, 2 biotinylated mouse
monoclonal anti-cTnI antibodies, magnetic
particles conjugated with streptavidin | Mouse monoclonal anti-human cTnl
alkaline phosphatase conjugate, magnetic
particles coated with mouse monoclonal
anti-human cTnl |
| Indications for
Use | 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. | No risk stratification indication |
3
| Characteristic | Predicate Device
ADVIA Centaur® TnI-Ultra™
K053020 | New Device
Access AccuTnI+3 |
|---------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Sample
Volume | 100μL | 55μL |
| Analytical
Measuring
Range | 0.008 ng/mL to 50 ng/mL | 0.03 ng/mL to 80 ng/mL |
| Acute
Myocardial
Infarction
(AMI) Cutoff | 0.78 ng/mL per WHO-defined cutoff | 0.03 ng/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 upper reference limit
(URL) is 0.075
ng/mL. SD ≤0.006 at concentrations
≤0.075 ng/mL |
Differences between the Access AccuTnI+3 Reagent and Calibrator and the Predicate
The UniCel Dxl 800 Access Immunoassay System and the previously cleared version of the UniCel Dx1 800 Access Immunoassay System were compared.
| Characteristic | Predicate Device
UniCel Dx1 800 Access
Immunoassay System
K023764 | New Device
UniCel DxI 800 Access
Immunoassay System |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Indications for Use | The UniCel Dxl 800 Access
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 | SPU, sample/reagent storage,
pipettor, bulk feeder, analytical,
carriage, substrate, pick and place,
fluidics, electronic/systems
computer, peripheral | same |
ﺮ
.
は
Similarities between the UniCel DxI 800 Access Immunoassay System and the Predicate
4
| Differences between the UniCel DxI 800 Access Immunoassay System and the Predicate | ||
|---|---|---|
| Characteristic | Predicate Device | |
| UniCel DxI 800 Access | ||
| Immunoassay System | ||
| K023764 | New Device | |
| UniCel DxI 800 Access | ||
| Immunoassay System | ||
| Thermal algorithm | ||
| capability | Not present | Present |
| Assay Protocol | ||
| File (APF) | AccuTnl APF | AccuTnI+3 APF with addition of the |
| thermal algorithm | ||
| Software | Version 2.4-4.4 | Version 4.5: added capability to implement |
| the thermal algorithm; 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 30°C ambient |
| 18°C to 36°C instrument case temperature |
Conclusion: The information provided above demonstrates that the new device, the Access AccuTn1+3 Reagent and Access AccuTnl+3 Calibrators for use on the UniCel DxI Access Immunoassay System, have the same intended use as the predicate device. The UniCel Dx1 800 Access Immunoassay System 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 UniCel Dx1 Access 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 is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administratio 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2013
Beckman Coulter Inc. c/o Kerrie Oetter 1000 Lake Hazeltine Dr. CHASKA MN 55318-1084
Re: K121790
Trade/Device Name: Access AccuTnl+3 Reagent, Access AccuTnI+3 Calibrator, UniCel 1 Dx1 800 Access Immunoassay System
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: September 04, 2013 Received: September 11, 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: CDRH 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 Parts 801 and 809); medical device 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 regulations (21 CFR Parts 801 and 809), please contact 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. 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.hum.
Sincerely yours,
Carol C. Benson -S for
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): K121790
Device Name: Access AccuTnl+3 Reagent, Access AccuTnl+3 Calibrator and UniCel Dxl 800 Access 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 UniCel Dxl Access Immunoassay Systems 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 1 (cTnl) levels in human serum and plasma using the UniCel Dxl Access Immunoassay Systems to aid in the diagnosis of myocardial infarction.
The UniCel Dxl 800 Access 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 × (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Devices and Radiological Health (OIR)
Ruth A. Chesler -S
Division Sign-Off Office of In Vitro Devices and Radiologic Health Evaluation and Safety 510(k)k)____________________________________________________________________________________________________________________________________________________________________
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