Cleared Traditional

Basal-IQ Technology (K193483) - FDA 510(k) Clearance

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

K193483 · Tandem Diabetes Care, Inc. · Chemistry device
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Feb 2020
Decision
73d
Days
Class 2
Risk

K193483 is an FDA 510(k) clearance for the Basal-IQ Technology. Classified as Interoperable Automated Glycemic Controller, Insulin Suspend (product code QJS), Class II - Special Controls.

Submitted by Tandem Diabetes Care, Inc. (San Diego, US). The FDA issued a Cleared decision on February 28, 2020 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1356 - 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 Tandem Diabetes Care, Inc. devices

Submission Details

510(k) Number K193483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2019
Decision Date February 28, 2020
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 88d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QJS Interoperable Automated Glycemic Controller, Insulin Suspend
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1356
Definition An Interoperable Automated Glycemic Controller, Insulin Suspend, Is A Device That Temporarily Suspend And Resumes Insulin Infusion From A Connected Infusion Pump Based On Specified Thresholds And Input Glucose Levels. Interoperable Automated Glycemic Controllers, Insulin Suspend, Are Designed To Reliably And Securely Communicate With Digitally Connected Devices To Allow Insulin Delivery Suspension And Resumption Commands To Be Sent, Received, Executed, And Confirmed. Interoperable Automated Glycemic Controllers, Insulin Suspend, Are Intended To Be Used In Conjunction With Digitally Connected Devices For The Purpose Of Maintaining Glycemic Control.
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.