Class I Microbiology device.
K831918 is an FDA 510(k) clearance for the LA-STAPH IDENTIFICATION SYSTEM. Classified as Kit, Screening, Staphylococcus Aureus (product code JWX), Class I - General Controls.
Submitted by Immuno-Mycologics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983.
This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.
| 510(k) Number | K831918 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 1983 |
| Decision Date | June 08, 1983 |
| Days to Decision | - |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Third-party Review | No - reviewed directly by FDA |
| Product Code | JWX Kit, Screening, Staphylococcus Aureus |
| Device Class | Class 1 - General Controls |
| CFR Regulation | 21 CFR 866.2660 |
Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.
Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.