The Contralco Alcohol Breath Tester is an in vitro medical device to semi-quantitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available at several detection cut-offs: 0.02, 0.04, 0.05, 0.06, 0.08, and 0.10 relative percent Blood Alcohol Concentration (BAC). The device is used only as a screening device and is only an indication of the possible presence of alcohol in the blood of the test subject.

Device Description

The Contralco Alcohol Breath Tester is a visual qualitative test for alcohol in human breath. The Tester contains chemicals that change color in the presence of alcohol vapors. The Tester is made up of 2 parts: the reagent and the plastic bag. One part contains light yellow crystals that change color when exposed to alcohol vapors. The other part (plastic bag) collects the volume of air necessary for the analysis. If alcohol is present, the crystals will change from yellow to light green. The number of crystals that change color will depend on the cut-off of the Tester and the amount of alcohol in the breath. The yellow crystals in the reagent are coated with Chromium VI oxide (CrO3) and sulfuric acid (H2SO4). The amount of these indicator chemicals is adjusted according to the selected cut-off of the tester. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium sulfate [Cr2(SO4)3]. The majority of crystals change from yellow to light green when alcohol vapors are present at a level equal to or exceeding the cut-off of the Tester. The Contralco Tester is available in several cut-offs (0.02, 0.04, 0.05, 0.06, 0.08 and 0.10%). The cut-off is printed on the Tester label and is expressed as a specific percentage of breath alcohol.

AI/ML Overview

The Contralco Alcohol Breath Tester is an in vitro medical device designed to semi-quantitatively detect alcohol in human breath. The device is a disposable screening tool for one-time use, available in several cut-offs: 0.02, 0.04, 0.05, 0.06, 0.08, and 0.10 relative percent Blood Alcohol Concentration (BAC). It is intended for over-the-counter use as a screening device to indicate the possible presence of alcohol in the blood.

A study was conducted to assess the safety and effectiveness of the Contralco Alcohol Breath Tester by comparing its performance against a quantitative comparator device (LION, manufactured by LION LABORATORIES LIMITED) and to confirm that consumers could correctly perform and interpret the test according to the package insert.

1. Acceptance Criteria and Reported Device Performance:

The document implicitly defines the acceptance criteria as the device results being "coherent" with the quantitative comparator device, with a specified effectiveness percentage. No explicit qualitative criteria for "coherent" are provided beyond the single reported disagreement.

Acceptance Criteria (Implicit)	Reported Device Performance (Contralco 0.05% Cut-off)
Results are coherent with a quantitative comparator device (LION).	58 out of 59 measurements were coherent with the quantitative device. One measurement was not coherent. This resulted in a reported 98% effectiveness.

2. Sample Size and Data Provenance:

Test Set Sample Size: 59 measures/volunteers.
Data Provenance: The study was conducted at the exit of a nightclub. The country of origin is not explicitly stated, but the submitter is from France. The study appears to be prospective, involving volunteers in a real-world setting.

3. Number of Experts and Qualifications for Ground Truth:

Number of Experts: One trained individual operated the quantitative comparator device (LION).
Qualifications of Experts: The individual operating the quantitative device is described as "trained." Further specific qualifications (e.g., years of experience, certification) are not provided.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The study design involved a direct comparison between the subject device (interpreted by volunteers) and a quantitative comparator device (operated by a trained individual) as the ground truth. There was no mention of multiple reviewers adjudicating the results of the Contralco device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No. This study does not appear to be an MRMC study. It focused on the Contralco device's performance as interpreted by consumers versus a quantitative reference, rather than comparing human reader performance with and without AI assistance.

6. Standalone Performance:

Standalone Performance: Yes, the study essentially tested the standalone performance of the Contralco Alcohol Breath Tester as interpreted by users. The "volunteers blew in balloons, and interpreted the results of the reactant." This represents the device's performance without a human expert interpreting its immediate output. The comparison data from the LION device served as the reference.

7. Type of Ground Truth Used:

Ground Truth: Quantitative measurements from a LION Alcohol Breath Tester, operated by a trained individual. This serves as a reference standard for Blood Alcohol Concentration (BAC).

8. Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This device is a chemical-based test kit and does not involve AI or machine learning models that require a training set. The calibration of the device with different cut-offs (e.g., 0.05% BAC) is an intrinsic property of its chemical composition, adjusted according to the desired detection cut-off.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth for Training Set: Not applicable. As noted above, there is no training set for this device. The "training" of the device is its manufacturing process where the amount of indicator chemicals (Chromium VI oxide and sulfuric acid) is adjusted to produce a color change at specific cut-off levels.

Summary

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144 Research Drive, Hampton, Virginia, 23666, USA P: 757-224-0177 F: 757-224-2045 E: cthornton@registrarcorp.com

Section 5.	510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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5.1	Date:	August 3, 2010
5.2	Submitter:
	Official Contact Person:On Behalf of:	Camille D. Thornton, Registrar CorpContralcoAvenue Mas Faugère BP 2334150 GignacFrance+33(0)4 67 91 32 40Contact: Daniel Calas
5.3	Device:
	Trade or Proprietary Name:Common or Usual Name:Classification Name:Product Code:Regulation Number:Device Class:	Contralco Alcohol Breath Tester (0.02, 0.04, 0.05, 0.06,0.08 and 0.10% BAC)Breath-alcohol testDevices, Breath Trapping, AlcoholDJZ862.3050Class I
5.4	Predicate Device:
	Contralco Alcohol Breath Tester is equivalent to: Redline disposable Alcohol BreathTester by Redline Products (Pty) Ltd, (K072953).

510(k) Summary

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144 Research Drive, Hampton, Virginia, 23666, USA P: 757-224-0177 F: 757-224-2045 E: cthornton@registrarcorp.com

510(k) Summary

5.5 Indication for Use:

ર્ રેણ Description of the Device:

If alcohol is present, the crystals will change from yellow to light green. The number of crystals that change color will depend on the cut-off of the Tester and the amount of alcohol in the breath.

The yellow crystals in the reagent are coated with Chromium VI oxide (CrO3) and sulfuric acid (H2SO4). The amount of these indicator chemicals is adjusted according to the selected cut-off of the tester. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium sulfate [Cr2(SO4)3]. The majority of crystals change from yellow to light green when alcohol vapors are present at a level equal to or exceeding the cut-off of the Tester. The Contralco Tester is available in several cut-offs (0.02, 0.04, 0.05, 0.06, 0.08 and 0.10%). The cut-off is printed on the Tester label and is expressed as a specific percentage of breath alcohol.

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510(k) Summary 144 Research Drive; Hampton, Virginia, 23666, USA P: 757-224-0177 F: 757-224-2045 E: cthornton@registrarcorp.com

5.7 Substantial Eguivalence:

Parameter	Contralco Device	Predicate: Redline (K072953)
Indication for use	Detects the presence of alcohol in the human breath	Detects the presence of alcohol in the human breath
Target Populations	Over the Counter	Over the Counter
Calibration/Accuracy Checks	None required	None required
Anatomical Site	Mouth	Mouth
Test sample	Human breath	Human breath
Collection device	Plastic bag	Plastic bag
Blowing time	12 seconds	12 seconds
Result Interpretation	Extent of color change	Extent of color change
Measurement Range	Separate devices are pre-calibrated to turn color at different cut-offs : 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, 0.10%	Separate devices are pre-calibrated to turn color at different cut-offs : 0.02%, 0.04%, 0.05%, 0.08%, 0.10%
Protection of alcohol breath test against the humidity	The reactant is placed in a glass tube with opercula at both extremities to assure total protection of the reactant against humidity and guarantee an optimal preservation of the test.	At either end of the tube, amorphous silica gel particles act as a protective barrier and are discarded before use.

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510(k) Summary

144 Research Drive, Hampton, Virginia, 23666, USA P: 757-224-0177 F: 757-224-2045 E: cthornton(@registrarcorp.com

5.8 Safety and Effectiveness:

A study was conducted to compare Contralco Alcohol Breath Tester with a quantitative comparator device. The purpose of the study was to determine if consumers could correctly perform and interpret the test according to the package insert. The quantitative comparator device is LION, manufactured by LION LABORATORIES LIMITED.

Multiple user studies were performed to establish that the user could read and understand the directions provided and properly use the device.

This study was conducted at the exit of a nightclub. Volunteers blew in balloons, and interpreted the results of the reactant. The volunteers then immediately provided another breath sample, which was analyzed using the quantitative device operated by a trained individual.

59 measures were taken.

The results are presented in the table below:

Contralco 0.05%	Quantitative Results
Tester Result	Less than 60%the cut-off(<0.02%)	Near Cut-OffNegative (0.02 to0.05%)	Near Cut-offPositive (≥0.05 to0.08 %)	More than+60% of cut-off (>0.08%)
Positive	0	0	10	17
Negative	18	13	1	0

The results from the Contralco Alcohol Breath Tester are coherent with the results of the quantitative comparator device (LION). Only one measurement is not coherent with the results of the quantitative comparator. In this case, the Contralco Alcohol Breath Tester is 98% effective.

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

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Contralco c/o Camille D. Thornton Registrar Corp Medical Devices 144 Research Drive Hampton, Virginia 23666

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Re: K100879

Trade Name: Contralco Breath Alcohol Tester Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-alcohol Test System Regulatory Class: Class I, Reserved Product Codes: DJZ Dated: July 12, 2010 Received: July 13, 2010

4 2089 AUG

Dear Ms. Thornton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRI's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ___ K100879

Contralco Alcohol Breath Tester Device Name:

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k/00879

Page 1 of

Regulation Number and Section

§ 862.3050 Breath-alcohol test system.

(a)
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.(b)
Classification. 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.