PYLO-PLUS

K052708 · Arj Medical, Inc. · LYR · May 1, 2006 · Microbiology

Device Facts

• Record ID: K052708
• Device Name: PYLO-PLUS
• Applicant: Arj Medical, Inc.
• Product Code: LYR · Microbiology
• Decision Date: May 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Indications for Use

Pylo-Plus is intended for the qualitative detection of the urease enzyme in gastric mucosal biopsy specimens and for the presumptive determination of Helicobacter pylori in symptomatic adult patients. For prescription use only

Device Story

Pylo-Plus is a rapid urease test for the presumptive detection of Helicobacter pylori. The device utilizes a chemical reaction to detect the presence of the urease enzyme in gastric biopsy samples. It is intended for single-use by medical professionals in a clinical gastroenterology setting to assist in the diagnosis of symptomatic patients. The test provides a qualitative result, which clinicians use to support clinical decision-making regarding H. pylori infection status.

Clinical Evidence

No clinical data provided; device relies on established chemical principles for urease detection.

Technological Characteristics

Single-use rapid urease test kit. Principle of operation: chemical detection of urease enzyme activity in gastric biopsy tissue. No electronic components, software, or energy sources.

Indications for Use

Indicated for the qualitative detection of urease enzyme in gastric biopsies for the presumptive determination of Helicobacter pylori in symptomatic patients undergoing screening in a gastroenterology setting.

Regulatory Classification

Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.

Submission Summary (Full Text)

{0}

1

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
K052708

B. Purpose for Submission:
For the qualitative detection of the urease enzyme in gastric mucosal biopsy specimens to aid in the presumptive determination of H. pylori in symptomatic adult patients

C. Measurand:
Urease enzyme

D. Type of Test:
Qualitative, Enzymatic

E. Applicant:
ARJ Medical Inc

F. Proprietary and Established Names:
Pylo - Plus

G. Regulatory Information:
1. Regulation section:
21 CFR Part 866.3110 Campylobacter fetus Serological Reagents
2. Classification:
I
3. Product code:
LYR – Campylobacter pylori
4. Panel:

{1}

83 - Microbiology

## H. Intended Use:

1. **Intended use:**

Pylo-Plus is intended for the qualitative detection of the urease enzyme in gastric mucosal biopsy specimens and for the presumptive determination of Helicobacter pylori in symptomatic adult patients.

2. **Indication(s) for use:**

Pylo-Plus is intended for the qualitative detection of the urease enzyme in gastric mucosal biopsy specimens and for the presumptive determination of Helicobacter pylori in symptomatic adult patients.

3. **Special conditions for use statement(s):**

For prescription use only

4. **Special instrument requirements:**

N/A

## I. Device Description:

Pylo-Plus is packaged in boxes of 50 test slides. It consists of a dry filter paper containing urea, phenol red (a pH indicator), buffers and a bacteriostatic agent, in a sealed plastic slide. If the urease enzyme of H. pylori is present in an inserted tissue sample, the resulting decomposition of urea causes the pH to rise resulting in a color change from yellow to bright magenta.

## J. Substantial Equivalence Information:

1. **Predicate device name:**

Medical Instruments Corp. Pronto Dry

2. **Predicate 510(k) number:**

K991248

3. **Comparison with predicate:**

{2}

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Detects urease enzyme | Same |
| Specimen type | Gastric mucosal biopsy | Same |
| Target population | Symptomatic patients with gastrointestinal disorders | Same |
| Test principle | Color change in response to urea level from yellow to red | Same |
| Storage | Room temperature | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Clinical sensitivity | 100% CI (97.0 – 100%) | 78.5% CI(59.0 – 83.9%) |
| Clinical specificity | 100% CI (97.0 – 100%) | 97.8% CI (88.2 – 99.9%) |

## K. Standard/Guidance Document Referenced (if applicable):

N/A

## L. Test Principle:

A gastric mucosal endoscopic biopsy is placed in the test well of the Pylo-Plus slide. The slide is then closed and the specially designed cover is squeezed to allow transfer of the biopsy contents onto the urea containing surface. If H. pylori is present, the urease in H. pylori converts the urea to ammonia which raises the pH and changes the color of the test surface from yellow to red, indicating a positive test.

H. pylori produces large amounts of urease enzyme. Tests for gastric urease are helpful for presumptive determination of H. pylori because mammalian cells do not produce urease and very few micro organisms survive in the stomach, except for H. pylori.

## M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

A reproducibility study was performed to determine the consistency of Pylo-Plus results between different subjects in different locations at different times

{3}

using varying levels of urease. Testing was done at 3 separate sites using 3 users at each facility. Two concentrations were at the lower limits of the testing threshold, two concentrations were at the high limits and one concentration was negative. All samples were masked. Positive and negative results were accurately recorded at each concentration so the samples produced the expected results 100% of the time.

b. Linearity/assay reportable range:
N/A

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
N/A

d. Detection limit:
N/A

e. Analytical specificity:
Bacterial cell suspensions at concentrations ranging from 10⁴ to 10⁸ were tested with the Pylo-Plus. At 10⁷, Yersinia enterocolitica was slightly positive, while at 10⁸, Proteus mirabilis and Pseudomonas aeruginosa were also positive. These microorganisms gave negative results at concentrations ranging from 10⁴ – 10⁶.

f. Assay cut-off:
N/A

2. Comparison studies:

a. Method comparison with predicate device:
100 patient biopsy samples were tested with the Pylo-Plus and Pronto Dry. There were 20 positive and 80 negative results with 100% positive and negative agreement.

b. Matrix comparison:
N/A

3. Clinical studies:

a. Clinical Sensitivity:
Biopsy samples from 100 patients were tested with the Pylo-Plus. Results

{4}

were compared to patient diagnosis. 20 patients were diagnosed with H.pylori infection and 80 were negative. The Pylo-Plus results were compared to clinical diagnosis and showed a sensitivity and specificity of 100%. C.I.(97.5 – 100%)

b. Clinical specificity:
Refer to (a.) above

c. Other clinical supportive data (when a. and b. are not applicable):
N/A

4. Clinical cut-off:
N/A

5. Expected values/Reference range:
In most cases, positive results can be expected to appear within 5 minutes. All positive results can be expected at one hour.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
1. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

5