LogoFDA 510(k) Search
K Number
K070640
Device Name
ARCHITECT STAT TROPONIN-1; MYOGLOBIN
Manufacturer
FISHER DIAGNOSTICS
Date Cleared
2007-09-13

(190 days)

Product Code
MMI,DDR
Regulation Number
862.1215
Type
Special
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ARCHITECT STAT Troponin-I is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of cardiac troponin-I in human serum or plasma on the ARCHITECT i 2000SR System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI).

ARCHITECT STAT Myoglobin is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of myoglobin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Myoglobin values are used to assist in the diagnosis of myocardial infarction (MI).

Device Description

Not Found

AI/ML Overview

This is an FDA Premarket Notification (510(k)) letter for the ARCHITECT STAT Troponin-I Immunoassay and ARCHITECT STAT Myoglobin Immunoassay. It confirms that the devices are substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies.

This type of FDA letter is an approval document, not a study report. To find the information you're looking for, you would typically need to consult:

  • The original 510(k) submission document itself (which includes the detailed performance data).
  • The device's Instructions for Use (IFU) or package insert, which often summarizes performance characteristics.
  • Clinical studies or validation reports associated with the device, usually referenced or summarized in the 510(k) submission.

Since the provided text does not contain the requested information, I cannot complete the table or answer the specific questions about the study design, sample sizes, or ground truth.

§ 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.