The ACON PCP One Step Phencyclidine Test Strip and ACON PCP One Step Phencyclidine Test Device are rapid chromatographic immunoassays for the qualitative detection of phencyclidine in human urine at a cut-off concentration of 25 ng/mL. They are intended for healthcare professionals including point of care sites.

Device Description

The ACON PCP One Step Phencyclidine Test Strip and ACON PCP One Step Phencyclidine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of phencyclidine in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the antibody to selectively detect elevated levels of phencyclidine in urine at a cut-off concentration of 25 ng/ml. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a red-colored line in the designated test region, while a negative urine specimen will generate a red-colored line in the test region. To serve as a procedural control, a red-colored line will always appear at the control region if the test has been performed properly.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance (ACON® PCP One Step Phencyclidine Test Strip)	Reported Device Performance (ACON® PCP One Step Phencyclidine Test Device)
Agreement vs. Predicate	Positive Agreement: High	98% (91% - 100% CI)	97% (88% - 100% CI)
	Negative Agreement: High	100% (98% - 100% CI)	100% (98% - 100% CI)
	Overall Agreement: High	99.5% (97% - 100% CI)	99% (97% - 100% CI)
Agreement vs. GC/MS	Positive Agreement: High	100% (93%-100% CI)	100% (93%- 100% CI)
	Negative Agreement: High	96% (92% - 99% CI)	97% (93% - 99% CI)
	Total Agreement: High	97% (94% - 99% CI)	98% (94% - 99% CI)
Cut-off concentration	25 ng/ml	25 ng/ml	25 ng/ml

Note: The acceptance criteria are implicitly derived from the comparative study. For devices seeking 510(k) clearance, "substantial equivalence" means the new device is as safe and effective as a legally marketed predicate device. The high agreement percentages with both the predicate and the GC/MS method indicate that the device meets the implicit acceptance criteria for substantial equivalence.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 212 clinical urine specimens.
- Data Provenance: The text does not explicitly state the country of origin. It indicates "clinical urine specimens," implying they were collected from real-world patients. The study is retrospective, as it utilized collected specimens for evaluation. The sample set also included 10% samples with drug concentrations at -25% to +25% of the cutoff, suggesting a targeted selection to test performance near the cutoff.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth for the test set was established using Gas Chromatography/Mass Spectrometry (GC/MS) analysis. GC/MS is a highly accurate and widely accepted method for drug identification and quantification, often considered the "gold standard" in toxicology. It does not typically involve human experts interpreting results in the same way, for example, a radiologist interprets an imaging study. Therefore, the "number of experts" is not applicable in the traditional sense for GC/MS. The expertise lies in the certified laboratory personnel operating and interpreting GC/MS data, but the document doesn't specify how many people were involved.
Adjudication method for the test set:
- Since the primary ground truth was established by GC/MS, an objective analytical method, a human adjudication method (like 2+1 or 3+1 by experts) was not applicable or described. The comparison was directly between the rapid test results and the GC/MS results.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not performed. This device is a rapid diagnostic test performed by healthcare professionals, not an AI-assisted diagnostic tool requiring human interpretation comparison. The study compared the device's accuracy against a predicate device and a reference method (GC/MS).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance study essentially represents a standalone performance evaluation. The ACON PCP One Step Phencyclidine Test Strip and Device are designed to provide a qualitative result directly (a line appearing or not). The study assessed the accuracy of these devices themselves without human interpretive intervention beyond reading the visual result. It's an "algorithm only" in the sense that the immunochromatographic reaction provides the "result."
The type of ground truth used:
- The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS), which is an objective, analytical "laboratory reference method."
The sample size for the training set:
- The document describes a clinical evaluation using 212 specimens, which served as the test set for performance assessment. As this is a rapid diagnostic test based on immunoassay principles, it does not involve machine learning algorithms that typically require a distinct "training set" of data. The "training" for such devices is inherent in their chemical and biological design and manufacturing process. Therefore, a separate training set as understood in AI/ML contexts is not applicable and not reported.
How the ground truth for the training set was established:
- As there is no separate "training set" in the machine learning sense for this type of device, the concept of establishing ground truth for a training set is not applicable. The device's underlying chemical/biological mechanisms are designed to detect phencyclidine, and its performance (agreement with GC/MS) confirms its ability to establish accurate "truth" compared to a gold standard.

Summary

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SUMMARY OF 510(k) SAFETY AND EFFECTIVENESS 8.

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The Assigned 510(k) number is: K011730

Submitter:

ACON Laboratories, Inc. 4108 Somento Valley Boulevard San Diego, California 92121

Tel.: 858-535-2030 Fax: 858-535-2038

Date: May 18, 2001

Contact Person: Edward Tung, Ph.D.

Product Names:

ACON® PCP One Step Phencyclidine Test Strip

ACON® PCP One Step Phencyclidine Test Device

Common Name:

Immunochromatographic test for the qualitative detection of phencyclidine in urine

Device Classification:

The ACON PCP One Step Phencyclidine Test Strip and ACON PCP One Step Phencyclidine Test Device are similar to other FDA-cleared devices for the qualitative detection of phencyclidine in urine specimens. These tests are used to provide a preliminary analytical result. (21 CFR 862) Phencyclidine test systems have been classified as Class II devices with moderate complexity.

Classification Name:

Phencyclidine test system

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Intended Use:

The ACON® PCP One Step Phencyclidine Test Strip and ACON PCP One Step Phencyclidine Test The ACON TCT One Blep I helleyeusme rose of the qualitative detection of phencycliding in assacciared Device at a cut-off concentration of 25 ng/ml. They are intended for healthcare professionals including point of care sites.

Description:

Description.
The ACON PCP One Step Phencyclidine Test Strip and ACON PCP One Step Phencyclidine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative Device are compoudive in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the antibody to selectively detect elevated levels of phencyclidine in urine at a cut-off concentration of 25 ng/ml. These tests can be performed without the use of an instrument.

A drug-positive urine specimen will not generate a red-colored line in the designated test region, while a negative urine specimen will generate a red-colored line in the test region. To serve as a woredural control, a red-colored line will always appear at the control region if the test has been performed properly.

Predicate Device:

LifeSign Status DSTM PCP One-Step Phencyclidine Test

510(k) Number: K961266

Distributor: LifeSign, LLC 71 Veronica Avenue Somerset, New Jersey 08873

Comparison to a Predicate Device:

A comparison of the features of the ACON PCP One Step Phencyclidine Test Strip and ACON PCP One Step Phencyclidine Test Device versus the LifeSign Status DSTM PCP One-Step Phencyclidine Test is shown below:

Both tests are assays intended for the qualitative detection of phencyclidine in urine . samples.
Both tests are intended as a screening method that provides a preliminary analytical test . result.
Both tests are immunochromatographic, lateral flow assays for the rapid detection of . phencyclidine with a visual, qualitative end result.
Both tests utilize the same basic immunoassay principles that rely on antigen/ antibody . interactions to indicate a positive or negative result.
Both tests have a cut-off phencyclidine concentration of 25 ng/ml. .

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Safety and Effectiveness Data:

Accuracy

A clinical evaluation was conducted using 212 clinical urine specimens which included 10% samples with the drug concentrations at -25% cutoff to +25% cutoff. This evaluation compared the test results of the ACON® PCP One Step Phencyclidine Test Strip and the Compared the tee term Phencyclidine Test Device against the LifeSign Status DSTM PCP One-Step Phencyclidine Test, as well as against the customary Gas Chromatography/Mass The comparisons of data obtained from this study yielded the Spectrometry analysis. following results:

ACON PCP One Step Phencyclidine Test Strip versus the LifeSign Status DSTM PCP One-Step Phencyclidine Test:

Positive Agreement: 56 / 57 = 98% (91% - 100%) Negative Agreement: 155 / 155 = 100% (98% - 100%) Overall Agreement: 211 / 212 = 99.5% (97% - 100%*) * 95% confidence intervals

ACON PCP One Step Phencyclidine Test Device versus the LifeSign Status DSTM PCP One-Step Phencyclidine Test:

Positive Agreement: 55 / 57 = 97% (88% - 100%) Negative Agreement: 155 / 155 = 100% (98% - 100%) Overall Agreement: 210 / 212 = 99% (97% - 100%*) * 95% confidence intervals

ACON PCP One Step Phencyclidine Test Strip versus GC/MS at the cutoff of 25 ng/ml:

Positive agreement with GC/MS: 50 / 50 = 100%(93%-100%) * Negative agreement with GC/MS: 156 / 162 = 96%(92% - 99%) * Total agreement with GC/MS: 206 / 212 = 97%(94% - 99%) * * 95% confidence intervals

ACON PCP One Step Phencyclidine Test Device versus GC/MS at the cutoff of 25 ng/ml:

Positive agreement with GC/MS: 50 / 50 = 100% (93%- 100%) * Negative agreement with GC/MS: 157 / 162 = 97%(93% - 99%) * Total agreement with GC/MS: 207 / 212 = 98%(94% - 99%) * * 95% confidence intervals

Conclusion:

These studies demonstrate the substantial equivalency between the ACON PCP One Step Phencyclidine Test Strip and ACON PCP One Step Phencyclidine Test Device and the LifeSign Status DSTM PCP One-Step Phencyclidine Test, which has already being marketed in the United States. It is also demonstrated that these rests are safe and effective in dececting phencyclidine at a concentration of 25 ng/mL. The POL study demonstrated that these tests are suitable for Health professionals including point-of-care sites.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 9 2001

Edward Tung, Ph.D. Director of Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Blvd. San Diego, CA 92121

Re: 510(k) Number: K011730 Trade/Device Name: ACON® PCP One Step Phencyclidine Test Strip and ACON® PCP One Step Phencyclidine Test Device

Regulatory Class: II Product Code: LCM Dated: June 1, 2001 Received: June 5, 2001

Dear Dr. Tung:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and v additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE 10.

K011730 510(k) Number:

Device Name: ACON® PCP One Step Phencyclidine Test Strip

ACON® PCP One Step Phencyclidine Test Device

Indications for Use:

(Division Sign-Off)
Division of Clinical
510(k) Numbe K11730

(Please do not write below this point)
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	Or	Over-The-Counter Use ______
(Per 21 CFR 801.109)

	Kesia Alexander for John Cooper
	(Division Sign-Off)
	Division of Clinical Laboratory Devices
510(k) Number	K011730

Regulation Number and Section

N/A