Cleared Traditional

K791874 - CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD

K791874 is the FDA 510(k) clearance for CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD by Gilford Diagnostics. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K791874 · Gilford Diagnostics · Chemistry device
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Oct 1979
Decision
26d
Days
Class 2
Risk

K791874 is an FDA 510(k) clearance for the CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD. 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 October 17, 1979 after a review of 26 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 K791874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1979
Decision Date October 17, 1979
Days to Decision 26 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
62d faster than avg
Panel avg: 88d · This submission: 26d
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 K791874.
CESIUM DILUENT (1.5 MM/L)
K800043 · Gilford Diagnostics · Jan 1980
PRINCIPAL ANALYTE REFERENCE SERUM
K792384 · Beckman Instruments, Inc. · Dec 1979
LANCER L-INA HUMAN REFERENCE SERUM
K792013 · Sherwood Medical Industries · Nov 1979
CALIBRATOR I
K791693 · Hi Chem, Inc. · Sep 1979
CALIBRATOR II
K791694 · Hi Chem, Inc. · Sep 1979
COMP. CLIN. CHEM. REF. SERUM-BENCHMARK
K780553 · Beckman Instruments, Inc. · May 1978