STP SYSTEM - SAF

K964026 · Sage Products, Inc. · LIO · Nov 7, 1996 · Microbiology

Device Facts

• Record ID: K964026
• Device Name: STP SYSTEM - SAF
• Applicant: Sage Products, Inc.
• Product Code: LIO · Microbiology
• Decision Date: Nov 7, 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-SAF is a stool specimen collection and transport device. Components include a conical centrifuge tube containing Sodium Acetate-Acetic Acid-Formalin (SAF) fixative, a cap with an integrated spoon, mixing balls, and an internal filter. User collects stool sample using the spoon, seals it in the tube, and shakes to mix the specimen with the fixative. The integral filter separates large debris to facilitate concentration. The device is used in clinical settings to prepare samples for permanent staining, concentration, or wet mount procedures. Healthcare providers perform microscopic examination of the processed specimen to identify intestinal parasites. The system ensures specimen preservation and standardized preparation, aiding in accurate diagnostic evaluation.

Clinical Evidence

Bench testing performed at independent clinical laboratories. Functional performance evaluated using a standardized method (Garcia and Bruckner, 1993) substituting human white blood cells for parasites. Samples were processed according to instructions, and permanent slides/wet mounts were examined for cell morphology, color, and smear adherence. Results confirmed satisfactory functional performance for microscopic examination.

Technological Characteristics

Conical centrifuge tube containing Sodium Acetate-Acetic Acid-Formalin (SAF) solution. Includes integrated spoon-in-cap, mixing balls, and internal filter for debris separation. Manual operation. Non-electronic, non-powered device.

Indications for Use

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

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® SAF Fixative

Submission Summary (Full Text)

{0}

NOV - 7 1996
SAGE PRODUCTS INC.
K9640260

# Pre-Market Notification: STP™ System - SAF

## 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- SAF |
| 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 product - since 1971"
815 TEK DRIVE • P.O. Box 9693 • CRYSTAL LAKE, IL 60014-9693
815-455-4700 • 800-323-2220 • FAX: [phone]
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SAGE PRODUCTS INC

Pre-Market Notification: STP™ System - SAF

# 16 510(k) Summary (Continued)

## Description

The product is comprised of a conical shaped centrifuge tube containing Sodium Acetate-Acetic Acid-Formalin (SAF) solution. A stand is provided to keep the tube in the upright position.

A spoon is attached to the cap and contained within the tube. The cap/spoon is removed and used to obtain a sample of the stool specimen. The sample is placed into the centrifuge tube and the cap/spoon assembly is securely closed. The collection tube is shaken causing the mixing balls to disrupt the specimen allowing complete coverage of the specimen with the fixative. The tube also contains an integral filter which separates large debris from the specimen and facilitates concentration of the specimen. The sample can be used for permanent staining, concentration, and/or wet mount procedures.

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

## Substantial Equivalence Comparison

The Sage STP™ System - SAF is substantially equivalent in principle and clinical performance to Meridian’s Para-Pak® SAF Fixative 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 one tube 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 a Sodium Acetate-Acetic Acid -Formalin solution.
3. The solutions have widespread use and acceptance for the purpose of fixing and preserving stool specimens. Both products allow for the standard methods of sample preparation for microscopic examination of stool specimens for parasites by permanent staining and/or concentration and wet mount.

"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]

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SAGE PRODUCTS INC

Pre-Market Notification: STP™ System - SAF

# 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 - Sodium Acetate-Acetic Acid- Formalin, 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 - SAF, 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

¹Innovative 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]

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