STP SYSTEM PVA WITH ZINC

K963986 · Sage Products, Inc. · LIO · Nov 8, 1996 · Microbiology

Device Facts

• Record ID: K963986
• Device Name: STP SYSTEM PVA WITH ZINC
• Applicant: Sage Products, Inc.
• Product Code: LIO · Microbiology
• Decision Date: Nov 8, 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 with Zinc and 10% Buffered Formalin) and a stand. Each cap features an integrated spoon for stool sample collection. After sample placement, tubes are shaken; internal mixing balls facilitate specimen disruption and fixative coverage. The PVA tube supports permanent staining; the Formalin tube includes an integral filter for debris separation and concentration for wet mount examination. Used in clinical laboratory settings by technicians to prepare specimens for microscopic analysis. Facilitates parasite identification by preserving morphology, aiding clinical diagnosis of parasitic infections.

Clinical Evidence

Performance evaluation conducted at independent clinical laboratories using a standardized functional test method. Study utilized human stool specimens spiked with human buffy coat (white blood cells) as a surrogate for parasites. 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 demonstrated satisfactory functional performance, confirming the system enables successful microscopic examination of stool specimens.

Technological Characteristics

Two-tube system; materials include conical centrifuge tubes, caps with integrated spoons, and internal mixing balls. Fixatives: Polyvinyl Alcohol (PVA) with Zinc and 10% Buffered Formalin. Formalin tube includes integral filter for debris separation. Manual operation; no energy source required. Non-sterile collection system.

Indications for Use

Indicated for the collection, transport, preservation, and preparation of human stool specimens for the identification of intestinal parasites via microscopic examination.

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® ZN-PVA/Formalin Kit

Submission Summary (Full Text)

{0}

SAGE PRODUCTS INC.
K963986
Nov. 8, 1996
Pre-Market Notification: STP™ System - PVA with Zinc

## 16 Study 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 Zinc |
| 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 Zinc

## 16 510(k) Summary (Continued)

### Description

The product contains two conical shaped centrifuge tubes. One tube contains Polyvinyl Alcohol with Zinc 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 Zinc is substantially equivalent in principle and clinical performance to Meridian’s Para-Pak® ZN-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 Zinc 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]

page 21 of 23

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SAGE PRODUCTS INC

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

## 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 Zinc, 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 Zinc, 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]