Cleared Traditional

K120900 - I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 (FDA 510(k) Clearance)

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

K120900 · Cliniqa Corporation · Hematology device
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May 2013
Decision
431d
Days
Class 2
Risk

K120900 is an FDA 510(k) clearance for the I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Cliniqa Corporation (San Marcos, US). The FDA issued a Cleared decision on May 31, 2013 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 Cliniqa Corporation devices

Submission Details

510(k) Number K120900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2012
Decision Date May 31, 2013
Days to Decision 431 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
318d slower than avg
Panel avg: 113d · This submission: 431d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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.