Cleared Traditional

K203434 - BlueStar Rx (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence.

K203434 · Welldoc, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
289d
Days
Class 2
Risk

K203434 is an FDA 510(k) clearance for the BlueStar Rx. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Welldoc, Inc. (Columbia, US). The FDA issued a Cleared decision on September 8, 2021 after a review of 289 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 868.1890 - 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 Welldoc, Inc. devices

Submission Details

510(k) Number K203434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2020
Decision Date September 08, 2021
Days to Decision 289 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
201d slower than avg
Panel avg: 88d · This submission: 289d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NDC Calculator, Drug Dose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02813343 Completed Interventional

Evaluate the Value of Telehomecare for Diabetes

221
Patients (actual)
1
Site
Supportive_care
Purpose
Single blind
Masking
Condition studied Type 2 Diabetes
Study design Crossover
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Sacha Bhatia, MD, FRCP(C)
Sponsor Women's College Hospital
Started 2016-04-01 → Primary completion 2017-06-01
Primary outcome
Glucose control (HbA1c levels)
Secondary outcome
Patient reported health outcomes and utilization - ER visit
Study completed - no results published. This trial concluded in 2017 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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