Cleared Traditional

K802631 - CREATININE STANDARDS

K802631 is an FDA 510(k) clearance for CREATININE STANDARDS, manufactured by Gilford Diagnostics. The device is a Class 2 Chemistry device with product code JIS cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K802631 · Gilford Diagnostics · Chemistry device
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Dec 1980
Decision
49d
Days
Class 2
Risk

K802631 is an FDA 510(k) clearance for the CREATININE STANDARDS. Classified as Calibrator, Primary (product code JIS), 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

FDA 510(k) Submission Details - K802631

510(k) Number K802631 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.

JIS Device Classification - Class 2, Special Controls

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 112
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K802631.
EMIT-TFG PRISMA THYROXINE CALIBRATORS
K810587 · Syva Co. · Mar 1981
CHOLESTEROL STANDARD
K810092 · Anco Medical Reagents & Assoc. · Feb 1981
GLUCOSE STANDARD
K810091 · Anco Medical Reagents & Assoc. · Jan 1981
UV URIC ACID STANDARDS
K801501 · The Dow Chemical Co. · Sep 1980
SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH)
K801665 · Miles Laboratories, Inc. · Aug 1980
EMIT AAII THYROXINE CALIBRATORS
K801287 · Syva Co. · Jun 1980