Cleared Traditional

K812861 - CHOLESTEROL CALIBRATORS

K812861 is the FDA 510(k) clearance for CHOLESTEROL CALIBRATORS by Gilford Diagnostics. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K812861 · Gilford Diagnostics · Chemistry device
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Oct 1981
Decision
10d
Days
Class 2
Risk

K812861 is an FDA 510(k) clearance for the CHOLESTEROL CALIBRATORS. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Gilford Diagnostics (Mchenry, US). The FDA issued a Cleared decision on October 23, 1981 after a review of 10 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 K812861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1981
Decision Date October 23, 1981
Days to Decision 10 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
78d faster than avg
Panel avg: 88d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
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 - JIS Calibrator, Primary

All 93
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K812861.
SYVA ADVANCE STANDARDIZATION KIT 01
K820698 · Syva Co. · Apr 1982
FLAME PHOTOMETER CALIBRATION STANDARDS
K813505 · Fisher Scientific Co., LLC · Dec 1981
TRIGLYCERIDE CALIBRATORS
K813478 · Gilford Diagnostics · Dec 1981
BIO SET TM SUBSTRATE CALIBRATORS
K810963 · Boehringer Mannheim Corp. · Apr 1981
EMIT-TFG PRISMA THYROXINE CALIBRATORS
K810587 · Syva Co. · Mar 1981
CREATININE STANDARDS
K802631 · Gilford Diagnostics · Dec 1980