Cleared Traditional

BLOOD GAS QUALITY CONTROL SOFT-86000F (K831574) - FDA 510(k) Clearance

Class I Hematology device.

K831574 · Computermate, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1983
Decision
151d
Days
Class 1
Risk

K831574 is an FDA 510(k) clearance for the BLOOD GAS QUALITY CONTROL SOFT-86000F. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Computermate, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 151 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2100 - 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.

View all Computermate, Inc. devices

Submission Details

510(k) Number K831574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1983
Decision Date October 14, 1983
Days to Decision 151 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 113d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
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 - JQP Calculator/data Processing Module, For Clinical Use

All 77
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K831574.
CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM
K892060 · Syva Co. · Aug 1989
COBAS MFC
K885292 · Roche Diagnostic Systems, Inc. · Mar 1989
DIRECT READOUT MODULE ACCESSORY
K861412 · E.I. Dupont DE Nemours & Co., Inc. · May 1986
SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER
K850659 · Syva Co. · Apr 1985
DUPONT LINEARIZATION MODULE
K832746 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1983
EMIT CLINICAL PROCESSOR #CP-5000
K822932 · Syva Co. · Nov 1982