Cleared Traditional

K802633 - BUN/GLUCOSE STANDARDS

K802633 is the FDA 510(k) clearance for BUN/GLUCOSE STANDARDS by Gilford Diagnostics. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K802633 · Gilford Diagnostics · Chemistry device
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Dec 1980
Decision
49d
Days
Class 2
Risk

K802633 is an FDA 510(k) clearance for the BUN/GLUCOSE STANDARDS. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Gilford Diagnostics (Mchenry, US). The FDA issued a Cleared decision on December 11, 1980 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Diagnostics devices

Submission Details

510(k) Number K802633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1980
Decision Date December 11, 1980
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 Chemistry devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 201
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K802633.
HITACHI 705 CALIBRATOR
K811921 · Boehringer Mannheim Corp. · Jul 1981
BIO SET TM PHOSPHOROUS CALIBRATOR
K810964 · Boehringer Mannheim Corp. · Apr 1981
ALBUMIN/TOTAL PROTEIN STANDARDS
K802632 · Gilford Diagnostics · Dec 1980
COMBUNED CALCIUM AND PHOSPHORUS STD.
K802824 · Mallinckrodt Critical Care · Dec 1980
COMBINED GLUCOSE AND BUN STANDARDS
K802825 · Mallinckrodt Critical Care · Dec 1980
CENTRIFICHEM COMB. SERUM-BASED CALIB.
K802741 · Union Carbide Corp. · Dec 1980