Cleared Traditional

K183680 - i-STAT CHEM8+ cartridge with the i-STAT...

K183680 is an FDA 510(k) clearance for i-STAT CHEM8+ cartridge with the i-STAT..., manufactured by Abbott Point of Care, Inc.. The device is a Class 2 Hematology device with product code JPI cleared through the Traditional 510(k) pathway after a 427-day FDA review.

K183680 · Abbott Point of Care, Inc. · Hematology device
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Feb 2020
Decision
427d
Days
Class 2
Risk

K183680 is an FDA 510(k) clearance for the i-STAT CHEM8+ cartridge with the i-STAT 1 System. Classified as Device, Hematocrit Measuring (product code JPI), Class II - Special Controls.

Submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on February 28, 2020 after a review of 427 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Abbott Point of Care, Inc. devices

FDA 510(k) Submission Details - K183680

510(k) Number K183680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2018
Decision Date February 28, 2020
Days to Decision 427 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
314d slower than avg
Panel avg: 113d · This submission: 427d
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

Devices cleared under the same product code (JPI) and FDA review panel - the closest regulatory comparables to K183680.
i-STAT Hematocrit test with i-STAT Alinity System
K163342 · Abbott Laboratories · Aug 2017
MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94
K852482 · Em Diagnostic Systems, Inc. · Jul 1985
MICROHEMATOCRIT READER
K830578 · Fisher Scientific Co., LLC · Mar 1983
MICRO-HEMATOCRIT CENTRIFUGE 335/336
K823558 · Fisher Scientific Co., LLC · Jan 1983