Cleared Traditional

K781423 - DUAL COMPONENT STANDARDS

K781423 is an FDA 510(k) clearance for DUAL COMPONENT STANDARDS, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K781423 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1978
Decision
14d
Days
Class 2
Risk

K781423 is an FDA 510(k) clearance for the DUAL COMPONENT STANDARDS. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 31, 1978 after a review of 14 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K781423

510(k) Number K781423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1978
Decision Date August 31, 1978
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
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 184
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K781423.
SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT
K800770 · Sclavo, Inc. · Apr 1980
CALIBRATOR NO. 1 & 2, & WASH SOLUTION
K800220 · Fisher Scientific Co., LLC · Feb 1980
TSH STANDARDS & DILUENT
K792290 · Amersham Corp. · Dec 1979
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