STP SYSTEM-PVA WITH MERCURY

K964027 · Sage Products, Inc. · LIO · Nov 1, 1996 · Microbiology

Device Facts

• Record ID: K964027
• Device Name: STP SYSTEM-PVA WITH MERCURY
• Applicant: Sage Products, Inc.
• Product Code: LIO · Microbiology
• Decision Date: Nov 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2900
• Device Class: Class 1

Intended Use

Collection, transport, preservation and preparation of stool specimens containing intestinal parasites for microscopic examination

Device Story

STP™ System consists of two conical centrifuge tubes containing fixatives: Polyvinyl Alcohol (PVA) with Mercury and 10% Buffered Formalin. Each tube features a cap with an integrated spoon for stool sample collection. After sample placement, tubes are shaken; internal mixing balls facilitate specimen disruption and fixative coverage. The formalin tube includes an integral filter for debris separation and specimen concentration for wet mount examination. The PVA tube is used for permanent staining techniques. The system is provided with a biohazard-labeled transport bag. Used in clinical laboratory settings by laboratory personnel to prepare specimens for microscopic identification of parasites, aiding in the diagnosis of intestinal parasitic infections.

Clinical Evidence

Bench testing only. Performance evaluated at independent clinical laboratories using a standardized procedure based on Garcia and Bruckner (1993). Human stool specimens spiked with human buffy coat (white blood cells) were processed according to instructions. Endpoints included smear adherence to glass slides after permanent staining and preservation of typical cell morphology and color in permanent stains and wet mounts. Results were categorized as satisfactory or unsatisfactory; the system demonstrated successful functional performance.

Technological Characteristics

Two conical centrifuge tubes; one containing Polyvinyl Alcohol (PVA) with Mercury, one containing 10% Buffered Formalin. Includes integrated spoon-in-cap design and internal mixing balls. Formalin tube includes an integral filter for specimen concentration. Stand provided for upright storage. Non-electronic, manual device.

Indications for Use

Indicated for the collection, transport, preservation, and preparation of stool specimens for the identification of intestinal parasites via microscopic examination in patients requiring stool analysis.

Regulatory Classification

Identification

A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Predicate Devices

• Meridian Para-Pak® LV-PVA/Formalin Kit

Submission Summary (Full Text)

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K964027

SAGE

PRODUCTS INC.

Pre-Market Notification: STP™ System- PVA with Mercury NOV - 1 1996

## 16 510(k) Summary

| Submitter Name | Karen Pinto, Regulatory Affairs Manager |
| --- | --- |
| Company Name | Sage Products Inc. |
| Street Address | 815 Tek Drive, Crystal Lake, IL 60014 |
| Contact Person | Karen Pinto, Regulatory Affairs Manager |
| Telephone of Contact Person | 815-455-4700 ext. 1383 |
| Fax of Contact Person | 815-455-5599 |
| Date of Summary Preparation | September 30, 1996 |
| Device Name | |
| Trade or Proprietary Name | STP™ System- PVA with Mercury |
| Common Name | Fixative-preservative for intestinal parasite examination |
| Classification Name | Microbiological specimen collection and transport device (866.2900) |
| Intended Use | Collection, transport, preservation and preparation of stool specimens containing intestinal parasites for microscopic examination |

"innovative health care products since 1971"

815 TEK DRIVE • P.O. Box 9693 • CRYSTAL LAKE, IL 60014-9693

815-455-4700 • 800-323-2220 • FAX: [phone]

page 20 of 23

{1}

SAGE PRODUCTS INC

Pre-Market Notification: STP™ System- PVA with Mercury

## 16 510(k) Summary (Continued)

### Description

The product contains two conical shaped centrifuge tubes. One tube contains Polyvinyl Alcohol with Mercury and the other 10% Buffered Formalin. A stand is provided to keep the tubes in the upright position.

Both tubes have a spoon contained within the tube which is attached to the cap. The cap/spoon is removed and used to obtain a sample of the stool specimen. The sample is placed into the centrifuge tubes and the cap/spoon assembly is securely closed. The collection tubes are shaken causing the mixing balls to disrupt the specimen allowing complete coverage of the specimen with the fixative.

The sample in PVA can be used for permanent staining techniques. The tube with the 10% Buffered Formalin also contains an integral filter which separates large debris from the specimen facilitating concentration of the specimen for wet mount examination.

The product is contained in a bag labeled with the biohazard symbol which can be used for transport of the tubes containing samples.

### Substantial Equivalence Comparison

The Sage STP System-PVA with Mercury is substantially equivalent in principle and clinical performance to Meridian’s Para-Pak® LV-PVA/Formalin Kit for the routine collection, transport, preservation and preparation of stool specimens for identification of intestinal parasites by microscopic examination.

Similarities between the Sage and Meridian Products are listed below:

1. Both products have two tubes designed for the safe and convenient collection of a standardized quantity of stool specimen. They both have a spoon-in-cap design.
2. The tubes in both products contain general laboratory fixative solutions: One tube contains a Polyvinyl Alcohol with Mercury solution and the other tube contains 10% buffered Formalin.
3. The solutions have widespread use and acceptance for the purpose of fixing and preserving stool specimens. PVA allows permanent stain slides to be prepared from the specimen. Formalin is a fixative that is used primarily for preserving a specimen which will be concentrated and wet mounted on a slide.¹

"Innovative health care products since 1971"

815 TEX DRIVE • P.O. BOX 9693 • CRYSTAL LAKE, IL 60014-9693

815-455-4700 • 800-323-2220 • FAX: [phone]

{2}

SAGE PRODUCTS INC

Pre-Market Notification: STP™ System- PVA with Mercury

## 16 510(k) Summary (Continued)

## Performance Test Summary

**Test Name:** Performance Evaluation

**Purpose:** To evaluate the functional performance of Sage’s Stool Transport Processing System - Polyvinyl Alcohol with Mercury, using a standardized testing procedure.

**Summary of Method:** Specimens were evaluated at independent clinical laboratories. The quality control test method described in the instruction sheet for the product was used for assessing functional performance. This method is based on the procedure reported by Garcia and Bruckner¹ where white blood cells are used in lieu of parasites. White blood cells (buffy coat from uncoagulated human blood with high WBC count) are added to product tubes containing human stool specimens. Written instructions were then followed for the preparation and microscopic evaluation of permanent slides and wet mounts. Product function was evaluated as either satisfactory or unsatisfactory. For a satisfactory functional evaluation the smear must adhere well to the glass slides after permanent staining to allow for a thorough microscopic examination, and the added cells from the human buffy coat must be well-fixed and display typical morphology and color when the permanent stains and wet mounts are examined under a microscope.

**Conclusion:** The STP™ System - PVA with Mercury, when used according to current instructions, results in a successful microscopic examination of human stool specimens for parasites.

Garcia, L.S. and Bruckner, D.A., Diagnostic Medical Parasitology, 2nd Edition, Washington, D.C., American Society for Microbiology, 1993
*Innovative health care products since 1971*

815 TEK DRIVE • P.O. Box 9693 • CRYSTAL LAKE, IL 60014-9693
815-455-4700 • 800-323-2220 • FAX: [phone]