Cleared Traditional

K831574 - BLOOD GAS QUALITY CONTROL SOFT-86000F

K831574 is an FDA 510(k) clearance for BLOOD GAS QUALITY CONTROL SOFT-86000F, manufactured by Computermate, Inc.. The device is a Class 1 Hematology device with product code JQP cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K831574 · Computermate, Inc. · Hematology device
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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

FDA 510(k) Submission Details - K831574

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.

JQP Device Classification - Class 1, General Controls

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 56
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K831574.
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K823679 · Nuclear Medical Laboratories, Inc. · Jan 1983