Cleared Traditional

DADE FACTOR VIII CHROMOGENIC ASSAY (K884544) - FDA 510(k) Clearance

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

K884544 · Baxter Healthcare Corp · Hematology device
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Dec 1988
Decision
60d
Days
Class 2
Risk

K884544 is an FDA 510(k) clearance for the DADE FACTOR VIII CHROMOGENIC ASSAY. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on December 30, 1988 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - the FDA hematology 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.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K884544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1988
Decision Date December 30, 1988
Days to Decision 60 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 113d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 Hematology devices follow this clearance model.

Regulatory Peers - GGP Test, Qualitative And Quantitative Factor Deficiency

All 70
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K884544.
PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357
K897136 · Helena Laboratories · Feb 1990
DADE(R) PLASMINOGEN CHROMOGENIC ASSAY
K890409 · Baxter Healthcare Corp · Feb 1989
DADE PROTEIN C CHROMOGENIC ASSAY
K884881 · Baxter Healthcare Corp · Feb 1989
DADE FACTOR IX CHROMOGENIC ASSAY
K884551 · Baxter Healthcare Corp · Dec 1988
CALIBRATION REFERENCE PLASMA
K874940 · Baxter Healthcare Corp · Feb 1988
IL TEST 84668-15, FACTOR VIII CONTROL PLASMA
K864480 · Instrumentation Laboratory CO · Jan 1987