Cleared Traditional

ZETAPHASE-DIG (K822053) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K822053 · Biological & Diagnostic Products · Chemistry device
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Jul 1982
Decision
14d
Days
Class 2
Risk

K822053 is an FDA 510(k) clearance for the ZETAPHASE-DIG. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. (product code DON), Class II - Special Controls.

Submitted by Biological & Diagnostic Products (Mchenry, US). The FDA issued a Cleared decision on July 27, 1982 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - 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 Biological & Diagnostic Products devices

Submission Details

510(k) Number K822053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1982
Decision Date July 27, 1982
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
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.

Device Classification

Product Code DON Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
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 - DON Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep.

Devices cleared under the same product code (DON) and FDA review panel - the closest regulatory comparables to K822053.
DIGOXIN RIABEAD DIAGNOSTIC KIT
K803075 · Abbott Laboratories · Dec 1980
TECHNICON STAR SYSTEM
K791549 · Technicon Instruments Corp. · Sep 1979
QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA
K772422 · Bio-Rad · Feb 1978
DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS
K772098 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1977