Cleared Traditional

K800910 - GAL-PUT CONTROLS

K800910 is the FDA 510(k) clearance for GAL-PUT CONTROLS by Sigma Chemical Co.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K800910 · Sigma Chemical Co. · Chemistry device
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Apr 1980
Decision
8d
Days
Class 2
Risk

K800910 is an FDA 510(k) clearance for the GAL-PUT CONTROLS, NORMAL&DEFICIENT. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1980 after a review of 8 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 Sigma Chemical Co. devices

Submission Details

510(k) Number K800910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1980
Decision Date April 29, 1980
Days to Decision 8 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
80d faster than avg
Panel avg: 88d · This submission: 8d
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 K800910.
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
SODIUM/POTASSIUM (100/100 MEQ/E)
K800040 · Gilford Diagnostics · Jan 1980
SODIUM/POTASSIUM 140/5 MEQ/L)
K800041 · Gilford Diagnostics · Jan 1980
CESIUM DILUENT (1.5 MM/L)
K800043 · Gilford Diagnostics · Jan 1980