← Product Code [LCM](/productcode/LCM) · K041578

# QUICKSCREEN, MODELS 9177X AND 9178X (K041578)

_Phamatech · LCM · Sep 10, 2004 · CH · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K041578

## Device Facts

- **Applicant:** Phamatech
- **Product Code:** [LCM](/productcode/LCM.md)
- **Decision Date:** Sep 10, 2004
- **Decision:** SESE
- **Submission Type:** Special
- **Device Class:** Class U
- **Review Panel:** CH

## Indications for Use

Phamatech QuickScreen™ Model 9177X & 9178X is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentrations of this test are as follows: amphetamine; 1000 ng/ml, THC; 50 ng/ml, cocaine; 300 ng/ml, PCP 25 ng/ml, opiates; 2000 ng/ml, methamphetamines; 500 ng/ml. This assay is intended to assist in the prevention of drug abuse

## Device Story

Rapid, qualitative, one-step immunoassay for urine drug screening; detects amphetamine, THC, cocaine, opiates, PCP (9177X) or methamphetamines (9178X). Operates via visual color sandwich immunoassay; specific antibody-target drug-antibody complexes form on test strip. Intended for professional use in clinical settings. Healthcare providers interpret visual color changes to identify presence of target drugs/metabolites above specified cut-off concentrations. Results assist in clinical decision-making regarding drug abuse prevention.

## Clinical Evidence

Clinical sample correlation study performed. Results demonstrate >98% correlation compared to professional-use QuickScreen™ tests for qualitative detection of target drugs in urine.

## Technological Characteristics

Visual color sandwich immunoassay; lateral flow test strip format. Qualitative detection based on immunochemical binding. No specific materials or energy sources described beyond standard immunoassay components.

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K_041578

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for testing 5 drugs/ drug metabolites (cocaine, THC, amphetamine, opiates and methamphetamine) or (cocaine, THC, amphetamine, opiates and PCP) whereas the marketed device tests for 9 drugs/ drug metabolites (all of the above plus barbiturates, benzodiazepines, PCP and methadone).

4. Comparison Information similarities to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Statement and the Indications for Use Enclosure.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

revised:8/1/03

---

**Source:** [https://fda.innolitics.com/device/K041578](https://fda.innolitics.com/device/K041578)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com