Cleared Traditional

K160613 - Soberlink Cellular Device and Sober Sky Web Portal

K160613 is an FDA 510(k) clearance for Soberlink Cellular Device and Sober Sky..., manufactured by Soberlink Healthcare, LLC. The device is a Class 1 Toxicology device with product code DJZ cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K160613 · Soberlink Healthcare, LLC · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
133d
Days
Class 1
Risk

K160613 is an FDA 510(k) clearance for the Soberlink Cellular Device and Sober Sky Web Portal. Classified as Devices, Breath Trapping, Alcohol (product code DJZ), Class I - General Controls.

Submitted by Soberlink Healthcare, LLC (Huntington Beach, US). The FDA issued a Cleared decision on July 14, 2016 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3050 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Soberlink Healthcare, LLC devices

FDA 510(k) Submission Details - K160613

510(k) Number K160613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2016
Decision Date July 14, 2016
Days to Decision 133 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 87d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

DJZ Device Classification - Class 1, General Controls

Product Code DJZ Devices, Breath Trapping, Alcohol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3050
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 Consultant

Obelix Consulting, LLC
ELISA MALDONADO-HOLMERTZ

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02544581 Unknown Observational Industry-sponsored

Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare

300
Patients (est.)
1
Site
Condition studied Alcohol Use Disorder
Eligibility All sexes · 18 Years+
Principal investigator Ed Pigott, Ph.D.
Sponsor SoberLink, LLC (industry)
Started 2015-09-01 → Primary completion 2015-11-01
Primary outcome
Compliance rates (negative versus positive versus false positive alcohol test findings)
View full study on ClinicalTrials.gov

Regulatory Peers - DJZ Devices, Breath Trapping, Alcohol

All 8
Devices cleared under the same product code (DJZ) and FDA review panel - the closest regulatory comparables to K160613.
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
K123470 · Pas Systems International, Inc. · Apr 2013
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
K110614 · Seju Engineering Co., Ltd. · Nov 2011
MISSION BREATH ALCOHOL DETECTOR
K093143 · ACON Laboratories, Inc. · Jan 2010
POCKET BREATHALYZER. CONNECTABLES
K052448 · Connectables, LLC · Feb 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500
K053332 · Sentech Korea Corp. · Jan 2006
BREATHKEY MODEL G10/BREATHKEY MODEL G30X
K052804 · Omega Point Systems, LLC · Dec 2005