Cleared Traditional

K900017 - REP GLYCO CONTROL NORMAL(3209) AND ABNO...

K900017 is the FDA 510(k) clearance for REP GLYCO CONTROL NORMAL(3209) AND ABNO... by Helena Laboratories. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K900017 · Helena Laboratories · Hematology device
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Jan 1990
Decision
27d
Days
Class 2
Risk

K900017 is an FDA 510(k) clearance for the REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210). Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on January 29, 1990 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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 Helena Laboratories devices

Submission Details

510(k) Number K900017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1990
Decision Date January 29, 1990
Days to Decision 27 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
86d faster than avg
Panel avg: 113d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - JPK Mixture, Hematology Quality Control

All 133
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K900017.
RETIC-CHEX
K905524 · Streck Laboratories, Inc. · Feb 1991
QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE
K904637 · R&D Systems, Inc. · Oct 1990
CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED
K904464 · R&D Systems, Inc. · Oct 1990
NE-CHECK
K890767 · Streck Laboratories, Inc. · Mar 1989
CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE
K890749 · R&D Systems, Inc. · Feb 1989
MSI-DIFF PLUS
K880270 · Medical Specialties, Inc. · Mar 1988