(98 days)
Not Found
No
The description details a standard immunoassay technology (CMIA) and data analysis based on a standard curve, with no mention of AI or ML algorithms for data processing or interpretation.
No
This device is an in vitro diagnostic (IVD) test used to assist in the diagnosis of myocardial infarction by measuring cardiac troponin-I levels. It does not provide therapy or treatment to a patient.
Yes
The device quantitatively determines cardiac troponin-I (cTnI) values, which are explicitly stated to be "used to assist in the diagnosis of myocardial infarction (MI)."
No
The device description clearly outlines a chemical immunoassay process involving reagents, microparticles, and measurement of relative light units (RLUs) on a physical system (ARCHITECT i System). This indicates a hardware-dependent in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of cardiac troponin-l (cTnl) in human serum and plasma". This is a test performed on samples taken from the body, but outside the body (in vitro).
- Device Description: The description details a "Chemiluminescent Microparticle Immunoassay (CMIA)" which is a laboratory-based test method.
- Anatomical Site: It is listed as "Not Applicable (In vitro diagnostic)", further confirming its nature as a test performed outside the body.
- Performance Studies: The performance studies describe testing on "human serum and plasma" samples.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ARCHITECT STAT Troponin-I is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of cardiac troponin-I (cTnI) in human serum and plasma on the ARCHITECT i System with STAT capability. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI).
The ARCHITECT STAT Troponin-I Calibrators are for calibration of the ARCHITECT i 2000SR System when used for the quantitative determination of cardiac Troponin-I in human serum or plasma.
Product codes (comma separated list FDA assigned to the subject device)
MMI, JIT
Device Description
The ARCHITECT STAT Troponin-I assay is a two-step assay to determine the presence of cardiac troponin-I in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®.
In the first step, sample, assay diluent and anti-troponin-I antibody-coated paramagnetic microparticles are combined. After incubation and washing, anti-troponin-I acridinium labeled conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of troponin-I in the sample and the RLUs detected by the ARCHITECT i system optics. The concentration of troponin-I is read relative to a standard curve established with calibrators of known troponin-I concentration.
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)
The ARCHITECT® STAT Troponin-I assay is substantially equivalent to the ACCESS® AccuTnl assay in terms of precision, linearity, interferences, and stability as demonstrated in non-clinical performance data in this 510(k) submission.
The ARCHITECT STAT Troponin-I assay demonstrated sensitivity and specificity that is substantially equivalent to the ACCESS AccuTnl assay, using the optimal AMI "cut-off" of 0.30 ng/mL as indicated by clinical data in this 510(k) submission. The sample stability study evaluated ARCHITECT STAT Troponin-I assay using Lithium Heparin and Serum Separator collection tubes. There was no systematic gain or loss of the detectability of troponin-I in serum or plasma samples under any of the storage conditions evaluated in this study. A method comparison was also conducted with the ARCHITECT STAT Troponin-I and ACCESS AccuTnl assays and as a result, the two systems demonstrated substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The ARCHITECT STAT Troponin-I assay demonstrated sensitivity and specificity that is substantially equivalent to the ACCESS AccuTnl assay, using the optimal AMI "cut-off" of 0.30 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.
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ARCHITECT® STAT Troponin- I Assay May 5, 2004
sher Diagnostics A Fisher Scientific Company
6.3 Summary of Safety and Effectiveness
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
AUG 1 2 2004
Applicant Name:
Josefina Infantas, MSM Sr. Regulatory Affairs Specialist Fisher Diagnostics 8365 Valley Pike P.O. Box 307 Middletown, VA 22645 Phone: 540-869-8158 Fax: 540-869-8129
Establishment Registration Number: 1181121
Identification of Device:
Device Name: ARCHITECT® STAT Troponin-I immunoassay Proprietary/Trade Name: ARCHITECT® STAT Troponin-I immunoassay Common Name: Troponin-I test system Device Classification: Class II Governing Regulation: 21 CFR 862.1215 FDA Panel: Clinical Chemistry (75) Product Code: MMI
Identification of Predicate Device:
Access® AccuTnl Assay (K021814)
Intended Use of the Device:
ARCHITECT STAT Troponin-I is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of cardiac troponin-l (cTnl) in human serum and plasma on the ARCHITECT i System with STAT capability. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI).
Description of the Device:
The ARCHITECT STAT Troponin-I assay is a two-step assay to determine the presence of cardiac troponin-I in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®.
In the first step, sample, assay diluent and anti-troponin-l antibody-coated paramagnetic microparticles are combined. After incubation and washing, anti-troponin-l acridinium labeled conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemilyminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of troponin-I in the sample and the RLUs detected by the ARCHITECT i system optics. The concentration of troponin-I is read
Image /page/0/Picture/19 description: The image shows a handwritten alphanumeric string. The string is "K041192". The characters are written in a simple, slightly irregular style, suggesting they were written quickly or by someone without formal calligraphy training. The background is plain white.
A Fisher Scientific Company 8365 Valley Pike P.O. Box 307 Middletown, VA 22645-0307
540-869-3200 Tel: Fax: 540-869-5249
fishersci.com
1
ARCHITECT® STAT Troponin- I Assay May 5, 2004
relative to a standard curve established with calibrators of known troponin-l concentration.
Comparison of Technological Characteristics:
The ARCHITECT® STAT Troponin-I and the ACCESS® AccuTnl assays use a The ANOTH EST of CMA trioperimmunoassay (CMIA) method for the quantitative determination of cardiac troponin-I in human serum and plasma. Values obtained are used to assist in the diagnosis of myocardial infarction. Proclin® 300 is a presenvative used all reagent components (microparticles, diluent and conjugate) of the ACCESS ascu an roagent computhe diluent and conjugate of the ARCHITECT STAT Troponin-i contain Proclin® 300 as a preservative. The ARCHITECT STAT Troponin-1 microparticles contain an antimicrobial agent as a preservative. Both assays have microparticles contain an antimorsenal anti-troponin-l in TRIS buffer. The conjugates both contain mouse monoclonal anti-troponin-l.
Summary of Non-clinical Performance:
The ARCHITECT® STAT Troponin-I assay is substantially equivalent to the ACCESS® AccuTnl assay in terms of precison, linearity, interferences, and stability as demonstrated in non-clinical performance data in this 510(k) submission.
Summary of Clinical Performance:
The ARCHITECT STAT Troponin-I assay demonstrated sensitivity and specificity that is substantially equivalent to the ACCESS AccuTnl assay, using the optimal AMI "cut-off" of 0.30 ng/mL as indicated by clinical data in this 510(k) submission. The sample stability study evaluated ARCHITECT STAT Troponin-I assay using Lithium Heparin and Serum Separator collection tubes. There was no systematic gain or loss of the detectability of troponin-I in serum or plasma samples under any of the storage conditions evaluated in this study. A method comparison was also conducted with the ARCHITECT STAT Troponin-I and ACCESS AccuTnl assays and as a result, the two systems demonstrated substantial equivalence.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a black and white logo. The logo consists of three curved lines that resemble a bird in flight. The lines are arranged in a way that they appear to be overlapping each other. The logo is surrounded by text that is arranged in a circular pattern. The text is difficult to read due to the low resolution of the image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 2 2004
Ms. Josefina Infantas, MSM Sr. Regulatory Affairs Specialist Fisher Diagnostics 8365 Valley Pike PO Box 307 Middletown, VA 22645
K041192 Re:
Ro Froz ARCHITECT STAT Troponin- I Calibrators Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI, JIT Dated: August 5, 2004 Received: August 5, 2004
Dear Ms. Infantas:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have tevice would four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to stgms) the enactment date of the Medical Device Amendments, or to conninered pror to May 2017, in accordance with the provisions of the Federal Food, Drug, de nees that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, morelore, manns of the Act include requirements for annual registration, listing of general controls proficies gractice, 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 your device is etablifical controls. Existing major regulations affecting your device It may be subject to such additions controllations (CFR), Parts 800 to 895. In addition, FDA can be found in Title = nouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of advilsed that I Driver device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must or any I cacrates and regaranents, including, but not limited to: registration and listing (21
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Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ogin mixing of substantial equivalence of your device to a legally premaired notincation: The PDF intembers of 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, If you destions on the promotion and advertising of your device, please contact the Office of or questions on the promotion and Safety at (301) 594-3084. Also, please note the In I the Diaglessed Dorlov by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may ovain other general messans 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,
Jain 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
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6.1 Indications for Use
ARCHITECT STAT Troponin-I is a Chemiluminescent Microparticle AHCHITECT UTAT Troponin' Hopenin' House Mation of cardiac troponin-l Infridnoussay (Owling for the quema on the ARCHITECT i System with STAT (CTTI) in numan oram and I values are used to assist in the diagnosis of myocardial infarction (MI).
The ARCHITECT STAT Troponin-I Calibrators are for calibration of the The ANOHITEOT i 2000SR System when used for the quantitative determination of cardiac Troponin-I in human serum or plasma.
510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: ARCHITECT® STAT Troponin-I Immunoassay
Over-The-Counter Use Use Prescription × (21 CFR 807 Subpart C) -- AND/OR (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C. Benson
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510(k) K041192