Cleared Traditional

K960774 - MICRO21 WITH ANA

K960774 is the FDA 510(k) clearance for MICRO21 WITH ANA by Triangle Biomedical Sciences, Inc.. It is a Class 2 Hematology device (product code JOY) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K960774 · Triangle Biomedical Sciences, Inc. · Hematology device
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May 1996
Decision
86d
Days
Class 2
Risk

K960774 is an FDA 510(k) clearance for the MICRO21 WITH ANA. 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 May 22, 1996 after a review of 86 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

Submission Details

510(k) Number K960774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1996
Decision Date May 22, 1996
Days to Decision 86 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
27d faster than avg
Panel avg: 113d · This submission: 86d
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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X100 with Full Field Peripheral Blood Smear (PBS) Application
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SCANNING SYS., AUTO. COMP., ACS1000
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