Cleared Traditional

K953826 - ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA

K953826 is an FDA 510(k) clearance for ENZYME LINKED UMMINOABSORBENT 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 121-day FDA review.

K953826 · Pyramid Biological Corp. · Microbiology device
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Dec 1995
Decision
121d
Days
Class 2
Risk

K953826 is an FDA 510(k) clearance for the ENZYME LINKED UMMINOABSORBENT 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 14, 1995 after a review of 121 days - within the typical 510(k) review window.

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 Pyramid Biological Corp. devices

FDA 510(k) Submission Details - K953826

510(k) Number K953826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1995
Decision Date December 14, 1995
Days to Decision 121 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 slower than avg
Panel avg: 102d · This submission: 121d
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.