Wondfo Phencyclidine Urine Test and Wondfo Phencyclidine Urine are intended for the qualitative determination of Phencyclidine and Notriptyline (target analytes)at the specific cut-off concentration in human urine. They are intended for healthcare professional use and over the counter use.

Wondfo Phencyclidine Urine Test is an immunochromatographic assay for the qualitative determination of Phencyclidine in human urine at a cutoff concentration of 25ng/mL. The test is available in a dip card format and a cup format. It is intended for prescription use and over the counter use.

Device Description

Immunochromatograph assay for Phencyclidine and Notriptyline Urine Test using a lateral flow, one step system for the qualitative detection of Phencyclidine and Notriptyline (target analytes) in human urine. Each assay uses a monoclonal antibody-dye conjugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody in membrane.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or percentage format for performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which implies that the device's performance is expected to be similar to the legally marketed predicates.

However, the core performance aspect for these qualitative urine tests is their ability to correctly identify the presence or absence of the target analytes at specific cut-off concentrations. This is implicitly the acceptance criterion: accurate qualitative detection at the specified cut-off concentrations.

Specific Acceptance Criterion (Implied)	Reported Device Performance
Qualitative determination of Phencyclidine at 25 ng/mL cutoff.	The device is an immunochromatographic assay for qualitative determination of Phencyclidine at this cutoff. Its performance is considered "similar... and equivalent" to the predicate.
Qualitative determination of Nortriptyline at 1000 ng/mL cutoff.	The device is an immunochromatographic assay for qualitative determination of Nortriptyline at this cutoff. Its performance is considered "similar... and equivalent" to the predicate.
Consistent results with predicate devices regarding positive/negative detection around cutoff values.	The overall claim is "similar technological characteristics and performance to the predicate and are equivalent." No specific numerical performance data (e.g., sensitivity, specificity, accuracy) is provided in this summary document.

2. Sample Size Used for the Test Set and Data Provenance:

The provided document does not contain any information regarding:

The sample size used for any test set or clinical study.
The country of origin of any data.
Whether the data was retrospective or prospective.

This type of detail is typically found in a clinical study report or a more comprehensive performance data section of a 510(k), which is not fully included here. The summary focuses on the comparative features and the claim of substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The document does not contain any information regarding:

The number of experts used to establish ground truth.
The qualifications of any such experts.

4. Adjudication Method for the Test Set:

The document does not contain any information regarding any adjudication method (e.g., 2+1, 3+1, none) for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done or reported in this document. The device is an in-vitro diagnostic test for qualitative determination of analytes in urine, not an imaging device requiring human reader interpretation in the same way. The comparison is made against predicate devices, not against human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance assessment of the device (without explicit "human-in-the-loop" assistance for interpretation beyond reading the visual result) is implied. The device itself is an immunochromatographic assay that produces a visual result (line/no line) indicating positive or negative. The "study" mentioned is the comparison of the device's characteristics and performance to predicate devices to demonstrate substantial equivalence. The document states its indications for use are for "healthcare professional use and over the counter use," implying that lay users and professionals interpret the inherent results of the test.

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for performance evaluation. However, for drug screens, the preferred confirmatory method is often mentioned:

For Phencyclidine: GC/MS (Gas Chromatography/Mass Spectrometry) is the preferred confirmatory method.
For Notriptyline: GC/MS or HPLC (High-Performance Liquid Chromatography) is the preferred confirmatory method.

These lab-based analytical methods are considered the "gold standard" for establishing ground truth regarding the presence and concentration of drugs in urine.

8. The Sample Size for the Training Set:

The document does not provide any information about a training set or its sample size. For an immunochromatographic assay, the development process involves reagent selection, optimization, and characterization, rather than "training" an AI model with a distinct dataset.

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

As there's no mention of a "training set" in the context of an AI model, this question is not applicable. For the development and validation of the immunoassay itself, highly characterized samples (e.g., spiked urine samples with known concentrations of analytes, or clinical samples confirmed by GC/MS/HPLC) would typically be used to establish performance characteristics, but specific details are not provided in this summary.

Summary

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K 112395

TABLE 4

SUMMARY

SEP - 9 2011

Date the summary was prepared:

September 2, 2011

Submitter's name: Guangzhou Wondfo Biotech Co., Ltd. Address: South China University of Technology Guangzhou, P.R. China 510641 Phone: 012-86-20-32296069

Name of contact person: Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: 240-505-7880 Fax: 301-916-6231

Name of the device

Common or usual name:	Phencyclidine Urine Test
	Notriptyline Urine Test
Trade or proprietary name:	Wondfo Phencyclidine Urine Test
	Wondfo Notriptyline Urine Test

Classification: All are Class II medical devices with the following various product codes with Code of Federal Regulation references:

Product Code	CFR #
LCM	21CFR 862.3100
LFG	21CFR 862.3910

The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:

1). Acon Laboratories, Inc., ACON® One Step Drug Screen Test, K020771.

2). Acon Laboratories, Inc., Acon® TCA One Step Tricyclic Antidepressant Test, K021526

Description of the device:

Assay Principle: Immunochromatograph assay for Phencyclidine and Notriptyline Urine Test using a lateral flow, one step system for the qualitative detection of Phencyclidine and Notriptyline (target analytes) in human urine. Each assay uses a monoclonal antibody-dye conjugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody in membrane.

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6. Intended use of the device:

7. Comparison to the predicate device

A summary comparison of the features of the Wondfo Phencyclidine Urine Test and Wondfo Notriptyline Urine Test and the predicate devices is provided in the Table 1.

Item	Device	Predicate
Indication(s) foruse	For the qualitative determination ofPhencyclidine, Notriptyline individual in	Same (but the numberof drugs detecteddifferent)
	human urine.
Methodology	Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry.	Same
Type Of Test	Immunoassay principles that rely onantigen-antibody interactions to indicatepositive or negative result	Same
Results	Qualitative	Same
Specimen Type	Human urine	Same
Cut Off Values	PCP: 25 ng/mlTCA: 1000 ng/ml	Same (but the numberof drugs detecteddifferent)
Configurations	Cup, dip card	Card, dip card with anintegrated cup (same)
Intended Use	OTC Use & Prescription Use	Prescription Use

Table 1: Features comparison of Wondfo assays and the predicate devices

The Wondfo Phencyclidine Urine Test and Wondfo Notriptyline Urine Test have similar technological characteristics and performance to the predicate and are equivalent.

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Image /page/2/Picture/0 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 an eagle with its wings spread, facing to the right. The eagle is depicted in a simple, line-art style.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Guangzhou Wondfo Biotech Co., Ltd. c/o Joe Shia LSI International Inc 504 East Diamond Ave, Suite F Gaithersburg, MD 20878

Re: K112395

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

SEP - 9 2011

Trade/Device Name: Wondfo Nortriptyline Urine Test and Wondfo Phencyclidine Urine
Transe on and Tort Test Regulation Number: 21 CFR 862.3910 Regulation Name: Tricyclic antidepressant drug test system Regulatory Class: Class II Product Code: LFG, LCM Dated: August 15, 2011 Received: August 19, 2011

Dear Mr. Shia:

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 stars in the enclosure) to legally marketed predicated devices marketed in interstate comments on the endoming to regally marketed procession
Medical Device American and control on 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. Code of Federal Regulations
800 to 895. In addition, EDA more of little 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) (2) CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

If you desire specific advice for your device on our labeling regulation (2) CFR Part 801), please contact the Office of In Viro Diagnosic Device Or Jour Gevery at (30) ) 796-5450. Also, please con
regulation entitled. "Mishranding by reference to manages in a monglesse note the regulation entitled, "Mishranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biomeric's (OBB's) Division of Postmarket Surveillance at (30) 796-5760. For questions regarding the reporting of 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 CDRH'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 on your responsibilities under (be Act from the Division of Small
Manufacturers, International and Consumer Assistance at is toll-free number (80 560 ) 770 | Technicean and Collumics Assistance at its toll-free number (800) 638-204) or ( 301 ) 796)
5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resou

Sincerely yours,

signature

Courtney H. Lias, 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 Form

510(k) Number (if known): K112395

Device Name: Wondfo Phencyclidine Urine Test

Indications for Use:

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a conformed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Prescription Use ____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use_ X (21 CFR Part 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)

Division Sign Off

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

510(k) K112395

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Indications for Use Form

510(k) Number (if known): K112395

Device Name: Wondfo Notriptyline Urine Test

Indications for Use:

Wondfo Notriptyline Urine Test is an immunochromatographic assay for the qualitative determination of Notriptyline (major metabolite of Tricyclic Antidepressants) in human urine at a cutoff concentration of 1000 ng/mL. The test is available in a dip card format. It is intended for prescription use and over the counter use. The tests will yield preliminary positive results when the prescription drug Nortriptyline are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Nortriptyline in urine.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a conformed analytical result. GC/MS or HPLC is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Over the Counter Use X (21 CFR Part 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)

Division Sign Off

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

510(k) K-112395

Page 2 of_ 2

Regulation Number and Section

§ 862.3910 Tricyclic antidepressant drugs test system.

(a)
Identification. A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.(b)
Classification. Class II (special controls). A tricyclic antidepressant drugs test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).