Cleared Traditional

K971470 - MICRO21 WITH CEREBROSPINAL FLUID

K971470 is the FDA 510(k) clearance for MICRO21 WITH CEREBROSPINAL FLUID by Triangle Biomedical Sciences, Inc.. It is a Class 2 Hematology device (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

Submission Details

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
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.

Device Classification

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 8
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