(89 days)
Not Found
No
The summary describes a urine collection and stabilization device, not a system that processes data or images using AI/ML. The testing described focuses on the device's ability to preserve microbial viability, not on algorithmic performance.
No.
The device is a urine stabilization device intended for collection, transport, and storage of urine for bacterial and yeast culture, which is for diagnostic purposes, not therapeutic intervention.
No
The device is a urine stabilization device for collection, transport, and storage of urine for bacterial and yeast culture; it does not perform diagnostic analysis of the sample.
No
The device description clearly states it is a physical tube made of PET with a vacuum and contains a granulate stabilizer, indicating it is a hardware device for sample collection and preservation, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "collection, transport and storage of urine for bacterial and yeast culture." This is a diagnostic purpose, as the culture is performed to identify the presence and type of microorganisms in the urine, which aids in diagnosing infections.
- Device Description: The device is designed to stabilize the urine sample and preserve the bacteria and formed elements, ensuring the sample is suitable for subsequent diagnostic testing (culture).
- Performance Studies: The performance studies describe testing the device's ability to maintain the viability and recovery of microorganisms for microbiological testing, which is a key aspect of in vitro diagnostics.
- Predicate Device: The predicate device listed (BD Vacutainer Plus Plastic Urine C&S Tube) is also an IVD device used for similar diagnostic purposes.
The device is used in vitro (outside the body) to prepare a sample for a diagnostic test (culture). Therefore, it falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Greiner Vacuette Urine Count and Culture, Mannitol tube is a urine stabilization device intended for collection, transport and storage of urine for bacterial and yeast culture. Urine samples collected in the Greiner Vacuette Urine Count and Culture, Mannitol tube can be stored at 20-25°C for up to 48 h prior to culture. This device is intended for professional use only.
Product codes (comma separated list FDA assigned to the subject device)
JSM, LIO
Device Description
Vacuette Urine CCM tubes are tubes made of PET with a pre-defined vacuum to exact draw volumes. They are fitted with yellow Vacuette Safety Caps. The tube interior is sterile. The evacuated tube contains a fine particle granulate stabilizer to preserve the urine sample at 20-25°C for up to 48 hours. The stabilizer helps to preserve and protect the level of bacteria at collection and maintain typically formed elements in urine sediment.
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
professional use only.
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
Testing was performed for the suitability of Greiner CCM tube as sampling and transport system for microbiological specimen using procedures outlined in the Clinical Laboratory Standard Institute (CLSI) M40-A2 Quality Control of Microbiological Transport Systems. Viability and recovery testing was performed with recommendation from M40-A2 and FDA. ATCC cultures from 10 potential pathogens of Escherichia coli, Enterococcus faecalis, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus saprophyticus, Enterobacter cloacae, Klebsiella pneumoniae, Streptococcus agalactiae, Candida albicans. Candida glabrata were used to spike sterile filtered urine to 10° and 10° cfu/ml. All analyses were performed in triplicates at room temperature and refrigerated temperature.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The GBO CCM tube fulfills the requirements set in the CLSI standard M40-A2, "Quality Control of Microbiological Transport Systems" demonstrating that the recovered organism are within +/- 1 log from the original spiked concentration is considered acceptable performance. The data provided shows that acceptable performance was demonstrated for all organisms tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
recovered organism are within +/- 1 log from the original spiked concentration is considered acceptable performance.
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.
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
§ 866.2390 Transport culture medium.
(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, representing the department's mission to protect the health of all Americans. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
March 6, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
GREINER BIO-ONE NA INC. MANFRED ABEL QUALITY SYSTEM AND REGULATORY AFFAIRS 4238 CAPITAL DRIVE MONROE NC 28110
Re: K163436
Trade/Device Name: Greiner Vacuette Urine Count and Culture, Mannitol Tube Regulation Number: 21 CFR 866.2390 Regulation Name: Transport culture medium Regulatory Class: I Product Code: JSM, LIO Dated: December 5, 2016 Received: December 7, 2016
Dear Mr. Abel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Steven R. Gitterman -S
for Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163436
Device Name
Greiner Vacuette Urine Count and Culture, Mannitol tube
Indications for Use (Describe)
The Greiner Vacuette Urine Count and Culture, Mannitol tube is a urine stabilization device intended for collection, transport and storage of urine for bacterial and yeast culture. Urine samples collected in the Greiner Vacuette Urine Count and Culture, Mannitol tube can be stored at 20-25°C for up to 48 h prior to culture. This device is intended for professional use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Section 5. Premarket notification 510(k) Summary
| 1. SUBMITTER
Applicant Name: | Greiner Bio-One GmbH.
Bad Haller Strasse 32
4550 Kremsmuenster,
Austria |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Manfred Abel, M.S., MBA
Greiner Bio-One NA Inc.
4238 Capital Drive
Monroe, NC 28110
704 763 0855
Manfred.Abel@gbo.com |
| Establishment registration number: | 8020040 |
| Date prepared: | Nov 23, 2016 |
2. DEVICE - CLASSIFICATION
| Trade Name: | Greiner Vacuette Urine Count and Culture, Mannitol tube |
|---|---|
| Common name: | Greiner Vacuette CCM tube |
| Device: | Culture Media, Non-Propagating Transport |
| Regulatory Description: | Transport culture medium |
| Regulation Medical Specialty: | Microbiology |
| Product Code: | JSM |
| Regulation No: | 866.2390 |
| Class: | 1 |
| Review Panel: | Microbiology |
3. PREDICATE DEVICE - CLASSIFICATION
| Device name: | BD Vacutainer Plus Plastic Urine C&S Tube |
|---|---|
| 510(k) number: | K024240 |
| Device: | Culture Media, Non-Propagating Transport |
| Regulatory Description: | Transport culture medium |
| Regulation Medical Specialty: | Microbiology |
| Product Code: | JSM |
| Regulation No: | 866.2390 |
| Class: | 1 |
| Review Panel: | Microbiology |
4. DEVICE DESCRIPTION
Vacuette Urine CCM tubes are tubes made of PET with a pre-defined vacuum to exact draw volumes. They are fitted with yellow Vacuette Safety Caps. The tube interior is sterile.
4
The evacuated tube contains a fine particle granulate stabilizer to preserve the urine sample at 20-25°C for up to 48 hours. The stabilizer helps to preserve and protect the level of bacteria at collection and maintain typically formed elements in urine sediment.
5. INDICATION FOR USE
The Greiner Vacuette Urine Count and Culture, Mannitol tube is a urine stabilization device intended for collection, transport and storage of urine for bacterial and yeast culture. Urine samples collected in the Greiner Vacuette Urine Count and Culture, Mannitol tube can be stored at 20-25°C for up to 48 h prior to culture. This device is intended for professional use only.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Both the subject device and the predicate have the same fundamental scientific technology and technological characteristics. Both devices are comprised of clear plastic tubes.
| | Greiner Vacuette Urine CCM tube
(Count & Culture Mannitol) | BD Vacutainer Plus Plastic Urine
C&S Tube
(Culture and Sensitivity) |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA status | Under review | K024240 |
| Classification | Class 1 | Class 1 |
| Regulation | 866.2390 | 866.2390 |
| Product Code | JSM | JSM |
| Intended Use | The Vacuette Urine CCM tube is a urine
stabilization device intended for
collection, transport and storage of urine
for bacterial and yeast culture. Urine
samples collected in the Vacuette® Urine
CCM tube can be stored at 20-25°C for
up to 48 h prior to culture. This device is
intended for professional use only. | The BD Vacutainer™ PLUS Plastic
Urine C&S Preservative Tubes and
Kits are intended for the collection
and transport of urine samples for
culture and sensitivity testing of
bacteria.
The BD Vacutainer Plus Plastic
Urine C&S Preservation Tube is
filled with lyophilized urine
maintenance formula and evacuated
to draw approximately 4 - 10 ml
(depending on the tube size) of
urine. The lyophilized urine
maintenance formula can maintain
the bacterial population in the urine
specimen for a period of 48 hours at
room temperature levels comparable
to those urine specimens without
additive, held under refrigeration for
the same period of time |
| Manufacturer | Greiner Bio-One (GBO) | Becton, Dickinson and company
(BD) |
| Tube | clear plastic | clear plastic and glass |
| Tube volume | 13x75 mm - 4ml
16x100 mm - 5ml
16x100 mm - 10ml | 13x75 mm - 4ml
16x75 mm - 5ml
16x100 mm - 10ml |
| Cap | Safety cap, yellow | Conventional stopper, gray |
| Vacuum | predefined Vacuum | predefined Vacuum |
| Additive | boric acid, sodium formate, sodium
borate, mannitol | boric acid, sodium formate, sodium
borate, mannitol |
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| Storage | 20 – 25 °C | normal room condition |
|---|---|---|
| Storage stability at | ||
| room temperature | 48 hours | 48 hours |
| Sterile | Yes | yes |
The intended use of the Greiner Vacuette Urine CCM tube is similar to the predicate device. Both devices are intended for the collection and storage of urine samples for culture at room temperature for up to 48 hours. Based on the device features, principles of operation, and technological characteristics we believe Greiner CCM tube is substantially equivalent to the predicate device.
7. PERFORMANCE DATA
Testing was performed for the suitability of Greiner CCM tube as sampling and transport system for microbiological specimen using procedures outlined in the Clinical Laboratory Standard Institute (CLSI) M40-A2 Quality Control of Microbiological Transport Systems. Viability and recovery testing was performed with recommendation from M40-A2 and FDA. ATCC cultures from 10 potential pathogens of Escherichia coli, Enterococcus faecalis, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus saprophyticus, Enterobacter cloacae, Klebsiella pneumoniae, Streptococcus agalactiae, Candida albicans. Candida glabrata were used to spike sterile filtered urine to 10° and 10° cfu/ml. All analyses were performed in triplicates at room temperature and refrigerated temperature.
8. DISCUSSION / CONCLUSION
The GBO CCM tube fulfills the requirements set in the CLSI standard M40-A2, "Quality Control of Microbiological Transport Systems" demonstrating that the recovered organism are within +/- 1 log from the original spiked concentration is considered acceptable performance. The data provided shows that acceptable performance was demonstrated for all organisms tested.