Cleared Traditional

K780447 - URIC ACID REFERENCE SERA

K780447 is the FDA 510(k) clearance for URIC ACID REFERENCE SERA by Macomb Chemical Co.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K780447 · Macomb Chemical Co. · Chemistry device
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Jun 1978
Decision
94d
Days
Class 2
Risk

K780447 is an FDA 510(k) clearance for the URIC ACID REFERENCE SERA. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Macomb Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1978 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Macomb Chemical Co. devices

Submission Details

510(k) Number K780447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1978
Decision Date June 22, 1978
Days to Decision 94 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 88d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIT Calibrator, Secondary
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 - JIT Calibrator, Secondary

All 169
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K780447.
DUAL COMPONENT STANDARDS
K781423 · Abbott Laboratories · Aug 1978
T3 STANDARDS IN HUMAN SERUM
K781069 · Pcl-Ria, Inc. · Aug 1978
STANDARDS, HORMONE, THYROID STIMULATING
K781071 · Pcl-Ria, Inc. · Aug 1978
CALIBRATORS, CARBON DIOXIDE
K780295 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1978
PH CALIBRATION BUFFERS
K772106 · General Diagnostics · Dec 1977
ACA TRIGLYCERIDE CALIBRATOR
K771797 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977