Cleared Traditional

ANALYZER, IMPACT 100 (K790073) - FDA 510(k) Clearance

Class I Chemistry device.

K790073 · Gilford Instrument Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1979
Decision
42d
Days
Class 1
Risk

K790073 is an FDA 510(k) clearance for the ANALYZER, IMPACT 100. Classified as Analyzer, Enzyme, For Clinical Use (product code JJI), Class I - General Controls.

Submitted by Gilford Instrument Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 22, 1979 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2500 - 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: 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 Gilford Instrument Laboratories, Inc. devices

Submission Details

510(k) Number K790073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1979
Decision Date February 22, 1979
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJI Analyzer, Enzyme, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2500
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.

Regulatory Peers - JJI Analyzer, Enzyme, For Clinical Use

Devices cleared under the same product code (JJI) and FDA review panel - the closest regulatory comparables to K790073.
ABBOTT IMX 2 ANALYZER
K944731 · Abbott Laboratories · Dec 1994
ABBOTT IMX2 ANALYER
K931970 · Abbott Laboratories · Jun 1993
RADIAS AUTOMATED IMMUNOASSAY SYSTEM
K930898 · Bio-Rad · Apr 1993
QUICKRATE REACTION RATE ANALYZER
K780972 · Olympus Corp. · Aug 1978
LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE
K770401 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1977