Cleared Traditional

FITKIT I CHECKUP KIT (K821799) - FDA 510(k) Clearance

Class I Chemistry device.

K821799 · Patton, Boggs & Blow · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1983
Decision
424d
Days
Class 1
Risk

K821799 is an FDA 510(k) clearance for the FITKIT I CHECKUP KIT. Classified as Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) (product code CDM), Class I - General Controls.

Submitted by Patton, Boggs & Blow (Mchenry, US). The FDA issued a Cleared decision on August 16, 1983 after a review of 424 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1785 - the FDA in vitro diagnostics and chemistry 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 Chemistry submissions.

View all Patton, Boggs & Blow devices

Submission Details

510(k) Number K821799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1982
Decision Date August 16, 1983
Days to Decision 424 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
336d slower than avg
Panel avg: 88d · This submission: 424d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDM Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1785
What this classification means

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.