Cleared Traditional

K190898 - Sight OLO

K190898 is the FDA 510(k) clearance for Sight OLO by Sight Diagnostics , Ltd.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K190898 · Sight Diagnostics , Ltd. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
210d
Days
Class 2
Risk

K190898 is an FDA 510(k) clearance for the Sight OLO. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Sight Diagnostics , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on November 1, 2019 after a review of 210 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 Sight Diagnostics , Ltd. devices

Submission Details

510(k) Number K190898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2019
Decision Date November 01, 2019
Days to Decision 210 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
97d slower than avg
Panel avg: 113d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Hematology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice Hogan

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.

Clinical Evidence

ClinicalTrials.gov
NCT03595501 Completed Observational Industry-sponsored

Analytical and Clinical Performance Testing Plan

679
Patients (actual)
1
Site
Condition studied Hematology; Hematologic Test
Eligibility All sexes · 3 Months+ · Healthy volunteers accepted
Principal investigator Dr. Eldad Hod, Dr
Sponsor Sight Diagnostics (industry)
Started 2018-06-20 → Primary completion 2019-03-06 → Completed 2019-08-25
Primary outcome
Reproducibility of CBC parameters provided by the OLO device
Study completed - no results published. This trial concluded in 2019 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - GKZ Counter, Differential Cell

All 193
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