Cleared Traditional

K221309 - AI100 with Shonit (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221309 · Sigtuple Technologies Pvt. , Ltd. · Hematology device
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Sep 2023
Decision
502d
Days
Class 2
Risk

K221309 is an FDA 510(k) clearance for the AI100 with Shonit. Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by Sigtuple Technologies Pvt. , Ltd. (Bangalore, IN). The FDA issued a Cleared decision on September 19, 2023 after a review of 502 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Sigtuple Technologies Pvt. , Ltd. devices

Submission Details

510(k) Number K221309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2022
Decision Date September 19, 2023
Days to Decision 502 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
389d slower than avg
Panel avg: 113d · This submission: 502d
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 Consultant

Axteria Biomed Consulting, Inc.
Jinjie Hu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JOY Device, Automated Cell-locating

All 34
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