Cleared Traditional

K780447 - URIC ACID REFERENCE SERA

K780447 is an FDA 510(k) clearance for URIC ACID REFERENCE SERA, manufactured by Macomb Chemical Co.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K780447

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
Combination Product No
PCCP Authorized No
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.

JIT Device Classification - Class 2, Special Controls

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 217
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