Cleared Traditional

DADE(R) PLASMINOGEN CHROMOGENIC ASSAY (K890409) - FDA 510(k) Clearance

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

K890409 · Baxter Healthcare Corp · Hematology device
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Feb 1989
Decision
34d
Days
Class 2
Risk

K890409 is an FDA 510(k) clearance for the DADE(R) PLASMINOGEN 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 February 27, 1989 after a review of 34 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 K890409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1989
Decision Date February 27, 1989
Days to Decision 34 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
79d faster than avg
Panel avg: 113d · This submission: 34d
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 K890409.
FREE PROTEIN S REAGENT CAT. NO. 5363
K904247 · Helena Laboratories · Jan 1991
PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359
K896174 · Helena Laboratories · Mar 1990
PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357
K897136 · Helena Laboratories · Feb 1990
DADE PROTEIN C CHROMOGENIC ASSAY
K884881 · Baxter Healthcare Corp · Feb 1989
DADE FACTOR VIII CHROMOGENIC ASSAY
K884544 · Baxter Healthcare Corp · Dec 1988
DADE FACTOR IX CHROMOGENIC ASSAY
K884551 · Baxter Healthcare Corp · Dec 1988