← Product Code [MMI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MMI) · K070640 # ARCHITECT STAT TROPONIN-1; MYOGLOBIN (K070640) _Fisher Diagnostics · MMI · Sep 13, 2007 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MMI/K070640 ## Device Facts - **Applicant:** Fisher Diagnostics - **Product Code:** [MMI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MMI.md) - **Decision Date:** Sep 13, 2007 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 862.1215 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for 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 Story ARCHITECT Troponin-I and Myoglobin Reagent Kits; in vitro diagnostic assays for quantitative measurement of cardiac markers in human serum or plasma. Modification: addition of EDTA plastic tubes as acceptable specimen collection containers. Device operates on ARCHITECT analyzer platform; utilizes chemiluminescent microparticle immunoassay (CMIA) technology. Clinicians use results to aid in diagnosis of myocardial infarction. Modification validated via design control activities to ensure performance equivalence with previously cleared versions. ## Clinical Evidence No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission. ## Technological Characteristics In vitro diagnostic immunoassay reagents. Chemiluminescent microparticle immunoassay (CMIA) technology. Compatible with ARCHITECT analyzer systems. Modification involves specimen collection container compatibility (EDTA plastic tubes). ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} SPECIAL 510(k): Device Modification ODE Review Memorandum (Decision Making Document is Attached) To: THE FILE RE: DOCUMENT NUMBER k070640 This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary): 1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k041192 ARCHITECT Troponin-I Reagent Kit, k042924 ARCHITECT Myoglobin Reagent Kit 2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use). 3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for The addition of EDTA (plastic) tubes for plasma. 4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics. 5. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied c) A declaration of conformity with design controls. The declaration of conformity should include: i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. 6. A Truthful and Accurate Statement, a 510(k) Statement and the Indications for Use. The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MMI/K070640](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MMI/K070640) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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