Cleared Traditional

K954515 - ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

K954515 is an FDA 510(k) clearance for ENZYME LINKED IMMUNOABSORBENT ASSAY, manufactured by Pyramid Biological Corp.. The device is a Class 2 Microbiology device with product code GOM cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K954515 · Pyramid Biological Corp. · Microbiology device
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Dec 1995
Decision
83d
Days
Class 2
Risk

K954515 is an FDA 510(k) clearance for the ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA. Classified as Antisera, Cf, Rubella (product code GOM), Class II - Special Controls.

Submitted by Pyramid Biological Corp. (Van Nuys, US). The FDA issued a Cleared decision on December 20, 1995 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pyramid Biological Corp. devices

FDA 510(k) Submission Details - K954515

510(k) Number K954515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1995
Decision Date December 20, 1995
Days to Decision 83 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 102d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GOM Device Classification - Class 2, Special Controls

Product Code GOM Antisera, Cf, 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.