Cleared Traditional

ASTRA (K811381) - FDA 510(k) Clearance

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

K811381 · Chem-Elec, Inc. · Chemistry device
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Aug 1981
Decision
90d
Days
Class 2
Risk

K811381 is an FDA 510(k) clearance for the ASTRA. Classified as Ph Rate Measurement, Carbon-dioxide (product code JFL), Class II - Special Controls.

Submitted by Chem-Elec, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Chem-Elec, Inc. devices

Submission Details

510(k) Number K811381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1981
Decision Date August 13, 1981
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFL Ph Rate Measurement, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 Chemistry devices follow this clearance model.

Regulatory Peers - JFL Ph Rate Measurement, Carbon-dioxide

All 27
Devices cleared under the same product code (JFL) and FDA review panel - the closest regulatory comparables to K811381.
i-STAT CHEM8+ cartridge with the i-STAT 1 System
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K014034 · Beckman Coulter, Inc. · Dec 2001
SIGMA ELECTROLYTE REFERENCE REAGENT
K933696 · Sigma Chemical Co. · Jan 1994
SIGMA CO2 ALKALINE BUFFER REAGENT
K933691 · Sigma Chemical Co. · Dec 1993
SIGMA CO2 ACID REAGENT
K933692 · Sigma Chemical Co. · Dec 1993
SIGMA ELECTROLYTE BUFFER
K933695 · Sigma Chemical Co. · Oct 1993