Cleared Traditional

K950942 - CRIT-LINE HEMATOCRIT ALERT

K950942 is the FDA 510(k) clearance for CRIT-LINE HEMATOCRIT ALERT by In-Line Diagnostics Corp.. It is a Class 2 Hematology device (product code JPI) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K950942 · In-Line Diagnostics Corp. · Hematology device
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Mar 1995
Decision
27d
Days
Class 2
Risk

K950942 is an FDA 510(k) clearance for the CRIT-LINE HEMATOCRIT ALERT. Classified as Device, Hematocrit Measuring (product code JPI), Class II - Special Controls.

Submitted by In-Line Diagnostics Corp. (Riverdale, US). The FDA issued a Cleared decision on March 14, 1995 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6400 - 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 In-Line Diagnostics Corp. devices

Submission Details

510(k) Number K950942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1995
Decision Date March 14, 1995
Days to Decision 27 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
86d faster than avg
Panel avg: 113d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPI Device, Hematocrit Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6400
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 - JPI Device, Hematocrit Measuring

Devices cleared under the same product code (JPI) and FDA review panel - the closest regulatory comparables to K950942.
i-STAT CHEM8+ cartridge with the i-STAT 1 System
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MICROHEMATOCRIT READER
K830578 · Fisher Scientific Co., LLC · Mar 1983
MICRO-HEMATOCRIT CENTRIFUGE 335/336
K823558 · Fisher Scientific Co., LLC · Jan 1983