Cleared Traditional

K163342 - i-STAT Hematocrit test with i-STAT Alinity System

K163342 is an FDA 510(k) clearance for i-STAT Hematocrit test with i-STAT Alin..., manufactured by Abbott Laboratories. The device is a Class 2 Hematology device with product code JPI cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K163342 · Abbott Laboratories · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
266d
Days
Class 2
Risk

K163342 is an FDA 510(k) clearance for the i-STAT Hematocrit test with i-STAT Alinity System. Classified as Device, Hematocrit Measuring (product code JPI), Class II - Special Controls.

Submitted by Abbott Laboratories (Princton, US). The FDA issued a Cleared decision on August 22, 2017 after a review of 266 days - an extended review 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: 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.

FDA 510(k) Submission Details - K163342

510(k) Number K163342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2016
Decision Date August 22, 2017
Days to Decision 266 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
153d slower than avg
Panel avg: 113d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPI Device Classification - Class 2, Special Controls

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

All 14
Devices cleared under the same product code (JPI) and FDA review panel - the closest regulatory comparables to K163342.
i-STAT CHEM8+ cartridge with the i-STAT 1 System
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CRIT-LINE HEMATOCRIT ALERT
K950942 · In-Line Diagnostics Corp. · Mar 1995
CRIT-LINE
K924167 · Noninvasive Medical Technology Corp. · May 1993
STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES
K903698 · Statspin Technologies · Sep 1990
STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER
K902028 · Norfolk Scientific, Inc. · Jun 1990
CHART-TYPE MICRO HEMATOCRIT TUBE READER
K870511 · Norfolk Scientific, Inc. · Mar 1987
K163342 · i-STAT Hematocrit test with i-STAT Alinity System
Download PDF FDA Summary Abbott Laboratories