Cleared Traditional

K973050 - MICRO21 WITH WBC ESTIMATE

K973050 is an FDA 510(k) clearance for MICRO21 WITH WBC ESTIMATE, manufactured by Triangle Biomedical Sciences, Inc.. The device is a Class 2 Hematology device with product code JOY cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K973050 · Triangle Biomedical Sciences, Inc. · Hematology device
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Nov 1997
Decision
84d
Days
Class 2
Risk

K973050 is an FDA 510(k) clearance for the MICRO21 WITH WBC ESTIMATE. Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by Triangle Biomedical Sciences, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on November 7, 1997 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5260 - 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 Triangle Biomedical Sciences, Inc. devices

FDA 510(k) Submission Details - K973050

510(k) Number K973050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1997
Decision Date November 07, 1997
Days to Decision 84 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 113d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOY Device Classification - Class 2, Special Controls

Product Code JOY Device, Automated Cell-locating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5260
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 - JOY Device, Automated Cell-locating

All 20
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K973050.
TRACCELL 2000 SLIDE MAPPING SYSTEM
K982786 · Accumed Intl., Inc. · Oct 1998
MICRO21 WITH URINE SEDIMENT ANALYSIS
K982301 · Triangle Biomedical Sciences, Inc. · Aug 1998
WINSCAN AUTOMATED IMAGING SYSTEM
K980375 · Applied Imaging Corp. · Jun 1998
MICRO21 WITH CEREBROSPINAL FLUID
K971470 · Triangle Biomedical Sciences, Inc. · Sep 1997
TRACCELL 2000 SLIDE MAPPING SYSTEM
K964689 · Accumed Intl., Inc. · Aug 1997
MDX 2000, DIGITAL ANALYZER
K970824 · Shotwell & Carr, Inc. · May 1997