Cleared Traditional

K782094 - HILAR

K782094 is the FDA 510(k) clearance for HILAR by Hi Chem, Inc.. It is a Class 2 Pathology device (product code CGX) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K782094 · Hi Chem, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1979
Decision
34d
Days
Class 2
Risk

K782094 is an FDA 510(k) clearance for the HILAR. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Hi Chem, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1979 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.1225 - the FDA pathology 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 Hi Chem, Inc. devices

Submission Details

510(k) Number K782094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1978
Decision Date January 17, 1979
Days to Decision 34 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 77d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 Pathology devices follow this clearance model.

Regulatory Peers - CGX Alkaline Picrate, Colorimetry, Creatinine

All 110
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K782094.
ALKALINE BUFFER
K791688 · Hi Chem, Inc. · Sep 1979
PICRIC SOLUTION
K791689 · Hi Chem, Inc. · Sep 1979
REAGENT KIT, BAKERS DIAGNOSTIC
K790044 · J.T. Baker Chemical Co. · Feb 1979
SERUM, CREATININE DETERMINATIONS
K781884 · Fisher Scientific Co., LLC · Dec 1978
ULTRACHEM CREATININE 64972, CENTRIFUCHEM
K780514 · Harleco · May 1978
CREATININE, 64972
K772157 · Harleco · Dec 1977