Cleared Traditional

K771803 - ACA PHOSPHORUS CALIBRATOR

K771803 is the FDA 510(k) clearance for ACA PHOSPHORUS CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K771803 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry device
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Oct 1977
Decision
32d
Days
Class 2
Risk

K771803 is an FDA 510(k) clearance for the ACA PHOSPHORUS CALIBRATOR. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on October 25, 1977 after a review of 32 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K771803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1977
Decision Date October 25, 1977
Days to Decision 32 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
56d faster than avg
Panel avg: 88d · This submission: 32d
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 159
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K771803.
ACA TRIGLYCERIDE CALIBRATOR
K771797 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977
ACA CARBON DIOXIDE CALIBRATOR
K771801 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977
ACA IRON CALIBRATOR
K771802 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977
ACA AMMONIA CALIBRATOR
K771804 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977
CENTRIFICHEM TRIGLYCERIDE CALI. STD.
K771215 · Union Carbide Corp. · Jul 1977
CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET
K771216 · Union Carbide Corp. · Jul 1977