Cleared Traditional

K881655 - SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE ...

K881655 is the FDA 510(k) clearance for SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE ... by Biomedical Research & Development Laboratories, Inc.. It is a Class 1 Chemistry device (product code JJR) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K881655 · Biomedical Research & Development Laboratories, Inc. · Chemistry device
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May 1988
Decision
42d
Days
Class 1
Risk

K881655 is an FDA 510(k) clearance for the SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL. Classified as Electrolyte Controls (assayed And Unassayed) (product code JJR), Class I - General Controls.

Submitted by Biomedical Research & Development Laboratories, Inc. (Oklahoma City, US). The FDA issued a Cleared decision on May 27, 1988 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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: 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 Biomedical Research & Development Laboratories, Inc. devices

Submission Details

510(k) Number K881655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1988
Decision Date May 27, 1988
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJR Electrolyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJR Electrolyte Controls (assayed And Unassayed)

All 10
Devices cleared under the same product code (JJR) and FDA review panel - the closest regulatory comparables to K881655.
CIBA CORNING CERTAIN LYTE
K894576 · Ciba Corning Diagnostics Corp. · Oct 1989
QCLYTE PROTEIN-BASED ISE CONTROL
K895582 · Baxter Healthcare Corp · Oct 1989
DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET
K881773 · Casco Standards · Jun 1988
PROTEIN BASE ISE CONTROL
K880710 · Bionostics, Inc. · Mar 1988
AVL ISE-TROL ELECTROLYTE CONTROL
K863333 · Avl Scientific Corp. · Sep 1986
HUMAN SERUM ELECTROLYTE CONTROL-LIQUID
K834505 · Quantimetrix Corp. · Apr 1984