Cleared Traditional

K894522 - FPR DIGOXIN CALIBRATOR KIT

K894522 is an FDA 510(k) clearance for FPR DIGOXIN CALIBRATOR KIT, manufactured by Colony Laboratories, Inc.. The device is a Class 2 Toxicology device with product code DLJ cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K894522 · Colony Laboratories, Inc. · Toxicology device
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Sep 1989
Decision
67d
Days
Class 2
Risk

K894522 is an FDA 510(k) clearance for the FPR DIGOXIN CALIBRATOR KIT. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Colony Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on September 25, 1989 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - the FDA toxicology device 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.

FDA 510(k) Submission Details - K894522

510(k) Number K894522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date September 25, 1989
Days to Decision 67 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 87d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DLJ Device Classification - Class 2, Special Controls

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 Toxicology devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 122
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K894522.
INNOFLUOR DIGOXIN CALIBRATOR SET
K895826 · Innotron of Oregon, Inc. · Oct 1989
PRIMIDONE (FPIA) CALIBRATOR KIT
K895568 · Tudor Laboratories, Inc. · Sep 1989
VALPROIC ACID (FPIA) CALIBRATOR KIT
K895570 · Tudor Laboratories, Inc. · Sep 1989
FPR THEOPHYLLINE CALIBRATOR KIT
K894530 · Colony Laboratories, Inc. · Sep 1989
FPR TOBRAMYCIN CALIBRATOR KIT
K894532 · Colony Laboratories, Inc. · Sep 1989
FPR CARBAMAZEPINE CALIBRATOR KIT
K894520 · Colony Laboratories, Inc. · Aug 1989
K894522 · FPR DIGOXIN CALIBRATOR KIT
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