Cleared Traditional

K971470 - MICRO21 WITH CEREBROSPINAL FLUID

K971470 is an FDA 510(k) clearance for MICRO21 WITH CEREBROSPINAL FLUID, 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 147-day FDA review.

K971470 · Triangle Biomedical Sciences, Inc. · Hematology device
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Sep 1997
Decision
147d
Days
Class 2
Risk

K971470 is an FDA 510(k) clearance for the MICRO21 WITH CEREBROSPINAL FLUID. 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 September 16, 1997 after a review of 147 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Triangle Biomedical Sciences, Inc. devices

FDA 510(k) Submission Details - K971470

510(k) Number K971470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1997
Decision Date September 16, 1997
Days to Decision 147 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
34d slower than avg
Panel avg: 113d · This submission: 147d
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 21
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K971470.
MICRO21 WITH URINE SEDIMENT ANALYSIS
K982301 · Triangle Biomedical Sciences, Inc. · Aug 1998
WINSCAN AUTOMATED IMAGING SYSTEM
K980375 · Applied Imaging Corp. · Jun 1998
MICRO21 WITH WBC ESTIMATE
K973050 · Triangle Biomedical Sciences, Inc. · Nov 1997
TRACCELL 2000 SLIDE MAPPING SYSTEM
K964689 · Accumed Intl., Inc. · Aug 1997
MDX 2000, DIGITAL ANALYZER
K970824 · Shotwell & Carr, Inc. · May 1997
MICRO21 WITH ANA
K960774 · Triangle Biomedical Sciences, Inc. · May 1996