Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3050](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3050) → DJZ — Devices, Breath Trapping, Alcohol # DJZ · Devices, Breath Trapping, Alcohol _Clinical Toxicology · 21 CFR 862.3050 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ ## Overview - **Product Code:** DJZ - **Device Name:** Devices, Breath Trapping, Alcohol - **Regulation:** [21 CFR 862.3050](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3050) - **Device Class:** 1 - **Review Panel:** [Clinical Toxicology](/submissions/TX) ## Identification A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. ## Recent Cleared Devices (20 of 28) Showing 20 most recent of 28 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K160613](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K160613.md) | Soberlink Cellular Device and Sober Sky Web Portal | Soberlink Healthcare, LLC | Jul 14, 2016 | SESE | | [K123470](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K123470.md) | PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE | Pas Systems International, Inc. | Apr 29, 2013 | SESE | | [K110614](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K110614.md) | PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM | Seju Engineering Co., Ltd. | Nov 21, 2011 | SESE | | [K102225](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K102225.md) | ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST | Alcopro, Inc. | Apr 6, 2011 | SESE | | [K102338](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K102338.md) | BREATHSCN PRO | Akers Biosciences, Inc. | Jan 12, 2011 | SESE | | [K100879](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K100879.md) | CONTRALCO | Contralco | Aug 4, 2010 | SESE | | [K093143](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K093143.md) | MISSION BREATH ALCOHOL DETECTOR | ACON Laboratories, Inc. | Jan 28, 2010 | SESE | | [K091714](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K091714.md) | ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 | Skyfine Inc. Limited | Nov 18, 2009 | SESE | | [K090766](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K090766.md) | LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER | Lifeloc Technologies, Inc. | Jul 23, 2009 | SESE | | [K082080](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K082080.md) | ALCO TUBE PLUS | Alcotest Quebec | Apr 1, 2009 | SESE | | [K090067](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K090067.md) | BACTRACK SELECT BREATHALYZER, MODEL S80 | Khn Solutions, LLC | Mar 24, 2009 | SESE | | [K083801](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K083801.md) | BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 | Khn Solutions, LLC | Mar 19, 2009 | SESE | | [K082086](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K082086.md) | KEY RING ALCOHOL BREATHALYZER | The Ashley Collection, Inc. | Dec 19, 2008 | SESE | | [K081855](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K081855.md) | IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) | Canada, Inc. | Dec 19, 2008 | SESE | | [K080848](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K080848.md) | ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR | Q3 Innovations, LLC | Jul 25, 2008 | SESE | | [K063443](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K063443.md) | DRAEGER ALCOTEST 6510 | Drager Safety | Mar 11, 2008 | SESE | | [K072953](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K072953.md) | REDLINE ALCOHOL BREATH TESTER | Redline Products (Pty) , Ltd. | Jan 7, 2008 | SESE | | [K071067](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K071067.md) | BACTRACK LCD ALCOHOL DETECTOR | Khn Solutions, LLC | Sep 14, 2007 | SESE | | [K062545](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K062545.md) | RMI LCD ALCOHOL DETECTOR | Resource Management International, LLC | Apr 9, 2007 | SESE | | [K062971](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ/K062971.md) | BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS | Akers Biosciences, Inc. | Dec 18, 2006 | SESE | ## Top Applicants - Khn Solutions, LLC — 4 clearances - Akers Biosciences, Inc. — 3 clearances - Sentech Korea Corp. — 3 clearances - Q3 Innovations, LLC — 2 clearances - ACON Laboratories, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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