Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components and chemical fixative for specimen collection and preparation, with no mention of AI or ML.

Therapeutic

No.
The device is used for the collection, transport, preservation, and preparation of stool specimens for microscopic examination to identify intestinal parasites, which is a diagnostic purpose, not a therapeutic one.

Diagnostic

No

The device is a collection, transport, preservation, and preparation system for stool specimens, facilitating microscopic examination but not performing the diagnosis itself.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like a centrifuge tube, stand, spoon, cap, mixing balls, and an integral filter. It is a physical specimen collection and preparation system, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "Collection, transport, preservation and preparation of stool specimens containing intestinal parasites for microscopic examination." This clearly indicates the device is used to prepare a biological specimen (stool) for a diagnostic procedure (microscopic examination for parasites).
Device Description: The device is designed to collect, preserve, and prepare the stool sample for analysis. This preparation is a crucial step in the diagnostic process.
Anatomical Site: The device is used with "Stool specimens," which are biological samples taken from the human body.
Intended User / Care Setting: The intended users are "Independent clinical laboratories," which are settings where diagnostic testing is performed.
Performance Studies: The performance studies describe the evaluation of the device's ability to prepare specimens for microscopic examination, which is a diagnostic technique. The conclusion states that the device "results in a successful microscopic examination of human stool specimens for parasites."
Predicate Device: The predicate device listed is "Meridian's Para-Pak® SAF Fixative," which is a known IVD product used for similar purposes.

While the device itself doesn't perform the final diagnostic interpretation (that's done by the microscopist), it is an essential tool used in vitro (outside the body) to prepare a biological specimen for a diagnostic test. This fits the definition of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

866.2900

Device 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 centrifinge 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 Bruckner 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 STPTM System - SAF, when used according to current instructions, results in a successful microscopic examination of human stool specimens for parasites.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 866.2900 Microbiological specimen collection and transport device.

(a)
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.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo for SAGE PRODUCTS INC. The logo is in black and features a stylized, bold font. The word "SAGE" is in large letters, and "PRODUCTS INC" is in smaller letters below it. The logo has a simple, modern design.

K964026

NOV

7 1996

Pre-Market Notification: STP™ System - SAF

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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"

1

Image /page/1/Picture/0 description: The image shows the logo for SAGE PRODUCTS INC. The logo is in black and white, with the word "SAGE" in large, bold letters. Below the word "SAGE" is the phrase "PRODUCTS INC" in smaller letters. The logo has a simple, modern design.

Pre-Market Notification: STP™ System - SAF

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 centrifinge 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:

Both products have one tube designed for the safe and convenient collection of a 1. standardized quantity of stool specimen. They both have a spoon-in-cap design.
The tubes in both products contain a Sodium Acetate-Acetic Acid -Formalin solution. 2.
1. 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.4

"Innovative health care products since 1971"

2

Image /page/2/Picture/0 description: The image shows the logo for SAGE PRODUCTS INC. The logo is in black and white, with the word "SAGE" in large, bold letters. Below the word "SAGE" is the phrase "PRODUCTS INC" in smaller letters. A line underlines the phrase "PRODUCTS INC".

Pre-Market Notification: STP™ System - SAF

mmary (Contin) STO(k)

Performance Test Summary

l

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 STPTM 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

"Innovative health care products since 197 !"