Cleared Traditional

K780996 - RUBELISA TEST KIT

K780996 is an FDA 510(k) clearance for RUBELISA TEST KIT, manufactured by Microbiological Assoc.. The device is a Class 2 Microbiology device with product code GON cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K780996 · Microbiological Assoc. · Microbiology device
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Nov 1978
Decision
162d
Days
Class 2
Risk

K780996 is an FDA 510(k) clearance for the RUBELISA TEST KIT. Classified as Antigen, Cf (including Cf Control), Rubella (product code GON), Class II - Special Controls.

Submitted by Microbiological Assoc. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1978 after a review of 162 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - 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.

View all Microbiological Assoc. devices

FDA 510(k) Submission Details - K780996

510(k) Number K780996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1978
Decision Date November 22, 1978
Days to Decision 162 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 102d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GON Device Classification - Class 2, Special Controls

Product Code GON Antigen, Cf (including Cf Control), Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.