Cleared Traditional

SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM (K897118) - FDA 510(k) Clearance

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

K897118 · Medisense, Inc. · Toxicology device
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May 1990
Decision
135d
Days
Class 2
Risk

K897118 is an FDA 510(k) clearance for the SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Medisense, Inc. (Cambridge, US). The FDA issued a Cleared decision on May 10, 1990 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3030 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medisense, Inc. devices

Submission Details

510(k) Number K897118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1989
Decision Date May 10, 1990
Days to Decision 135 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 87d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDP Colorimetry, Acetaminophen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3030
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 Toxicology devices follow this clearance model.

Regulatory Peers - LDP Colorimetry, Acetaminophen

All 35
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K897118.
Acetaminophen
K202644 · Sekisui Diagnostics P.E.I., Inc. · Feb 2022
SEKURE Acetaminophen L3K Assay
K180835 · Sekisui Diagnostics P.E.I., Inc. · Feb 2019
DIMENSION VISTA FLEX REAGENT CARTRIDGES
K061655 · Dade Behring, Inc. · Jul 2006
ROCHE ACETAMINOPHEN
K013757 · Roche Diagnostics Corp. · Jan 2002
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
K011465 · Beckman Coulter, Inc. · Jun 2001
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL
K002974 · Dade Behring, Inc. · Oct 2000