Cleared Traditional

K842830 - IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K842830 · Bartels Immunodiagnostic Supplies, Inc. · Microbiology device
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Nov 1985
Decision
494d
Days
Class 2
Risk

K842830 is an FDA 510(k) clearance for the IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF. Classified as Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (product code GQN), Class II - Special Controls.

Submitted by Bartels Immunodiagnostic Supplies, Inc.. The FDA issued a Cleared decision on November 26, 1985 after a review of 494 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3305 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Bartels Immunodiagnostic Supplies, Inc. devices

Submission Details

510(k) Number K842830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1984
Decision Date November 26, 1985
Days to Decision 494 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
392d slower than avg
Panel avg: 102d · This submission: 494d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GQN Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
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.