Cleared Traditional

K781069 - T3 STANDARDS IN HUMAN SERUM

K781069 is the FDA 510(k) clearance for T3 STANDARDS IN HUMAN SERUM by Pcl-Ria, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K781069 · Pcl-Ria, Inc. · Chemistry device
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Aug 1978
Decision
49d
Days
Class 2
Risk

K781069 is an FDA 510(k) clearance for the T3 STANDARDS IN HUMAN SERUM. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Pcl-Ria, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978 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 Pcl-Ria, Inc. devices

Submission Details

510(k) Number K781069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1978
Decision Date August 14, 1978
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.

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 167
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K781069.
CALIBRATOR NO. 1 & 2, & WASH SOLUTION
K800220 · Fisher Scientific Co., LLC · Feb 1980
TSH STANDARDS & DILUENT
K792290 · Amersham Corp. · Dec 1979
DUAL COMPONENT STANDARDS
K781423 · Abbott Laboratories · 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