Greiner Vacuette Urine Count and Culture, Mannitol tube

K163436 · Greiner Bio-One Na, Inc. · JSM · Mar 6, 2017 · Microbiology

Device Facts

• Record ID: K163436
• Device Name: Greiner Vacuette Urine Count and Culture, Mannitol tube
• Applicant: Greiner Bio-One Na, Inc.
• Product Code: JSM · Microbiology
• Decision Date: Mar 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2390
• Device Class: Class 1

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.

Device Story

Device is a sterile, evacuated PET plastic tube with a yellow safety cap; contains fine particle granulate stabilizer (boric acid, sodium formate, sodium borate, mannitol). Used by healthcare professionals for urine collection; vacuum draws specific volume of urine. Stabilizer preserves bacterial/yeast populations and formed elements in urine sediment at 20-25°C for up to 48 hours. Facilitates transport to clinical laboratories for culture; enables room temperature storage as an alternative to refrigeration. Benefits patient by maintaining sample integrity for accurate diagnostic culture results.

Clinical Evidence

Bench testing only. Viability studies conducted per CLSI M40-A2 using representative urinary tract infection pathogens (E. coli, E. faecalis, P. mirabilis, P. aeruginosa, S. saprophyticus, E. cloacae, K. pneumoniae, S. agalactiae, C. albicans, C. glabrata). Samples spiked into pooled urine and stored at 20-25°C and 2-8°C for 48 hours. Results demonstrated recovery within +/- 1 log of original concentration, meeting acceptance criteria.

Technological Characteristics

PET plastic tube; evacuated for predefined draw volumes (4ml, 5ml, 10ml); yellow safety cap. Additives: boric acid, sodium formate, sodium borate, mannitol. Sterile interior. Principle: chemical stabilization of urine specimen. No electronic or software components.

Indications for Use

Indicated for professional use in the collection, transport, and storage of urine specimens for the culture of bacteria and yeast in patients requiring urinary tract infection assessment.

Regulatory Classification

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.

Predicate Devices

• BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tubes and Kits (K024240)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
K163436

B. Purpose for Submission:
To make a substantial equivalence determination for the Greiner Vacuette Urine Count and Culture, Mannitol tube for the collection, transport and storage of urine specimens for laboratory culture of bacteria and yeast.

C. Measurand:
Not Applicable

D. Type of Test:
Transport Culture Medium Device

E. Applicant:
Greiner Bio-One NA, Inc.

F. Proprietary and Established Names:
Greiner Vacuette Urine Count and Culture, Mannitol tube

G. Regulatory Information:
1. Regulation section:
21 CFR 866.2390; Transport Culture Medium
2. Classification:
Class I
3. Product code:
JSM; Culture Media, Non-Propagating Transport
LIO: Device, Specimen Collection

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4. Panel:
83- Microbiology

H. Intended Use:

1. Intended use(s):
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.

2. Indication(s) for use:
Same as the Intended use

3. Special conditions for use statement(s):
For prescription use only.

4. Special instrument requirements:
None.

I. Device Description:

The Greiner Vacuette Urine Count and Culture, Mannitol (CCM) tubes are tubes made of polyethylene terephthalate (PET) with a pre-defined vacuum to exact draw volumes. They are fitted with yellow Vacuette Safety Caps.

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 and yeast at collection and maintain typically formed elements in urine sediment.

J. Substantial Equivalence Information:

1. Predicate device name(s):
BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tubes and Kits

2. Predicate 510(k) number(s):
k024240

3. Comparison with predicate:

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| Similarities | | |
| --- | --- | --- |
| Item | Greiner Vacuette Urine
CCM tube
K163436 | BD Vacutainer Plus Plastic Urine C&S Tube
K024240 |
| Intended 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. | 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. |
| Single use device | Yes | Same |
| Volume | predefined Vacuum | Same |
| Storage | 20 – 25 °C | Same |
| Storage stability at room temperature | 48 hours | Same |
| Sterile | Yes | Same |

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| Differences | | |
| --- | --- | --- |
| Item | Greiner Vacuette Urine
CCM tube
K163436 | BD Vacutainer Plus Plastic Urine C&S Tube
K024240 |
| Tube | clear plastic | clear plastic and glass |
| Additives | boric acid, sodium formate, sodium borate, mannitol | boric acid, sodium formate and sodium borate |
| Tube sizes | 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 |

## K. Standard/Guidance Document Referenced (if applicable):

Quality Control of Microbiological Transport Systems; Approved Standard, M40-A2, Clinical and Laboratory Standards Institute (CLSI), Wayne, PA. 2014.

## L. Test Principle:

Not applicable

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

The performance characteristics of the Greiner Vacuette Urine CCM tubes were determined using organism recovery (i.e., viability) studies. The bacteria listed in Table 1 below were evaluated in this study. The organisms evaluated were representatives from bacterial species that are usually associated with urinary tract infections. Inoculation and organism recovery studies conducted in accordance with the Clinical Laboratory Standards Institute (CLSI) M40-A2 document.

To perform viability studies, organisms were diluted from $1.5 \times 10^{8} \mathrm{CFU/mL}$ (equivalent to a $0.5 \mathrm{McFarland}$ standard) down then spiked into pooled filter sterilized urine to get a final concentration of $1.5 \times 10^{4}$, $1.5 \times 10^{3}$, and $1.5 \times 10^{2} \mathrm{CFU/mL}$. The spiked urine samples were then placed in their respective Greiner Vacuette Urine CCM tubes in triplicates and held for 0, 24, 48 hours at room temperature $(20 - 25^{\circ} \mathrm{C})$ and at refrigerated temperature $(2 - 8^{\circ} \mathrm{C})$. At the designated time intervals, the Greiner Vacuette Urine CCM tubes were removed from storage and $100 \mu \mathrm{L}$ from each urine tube was removed and plated. The average plate count results from the organism recovery study are shown in Table 1 below. Demonstrating that the recovered organism concentration is within $+/- 1$ log of the original spiked concentration is considered acceptable performance. The data provided shows that acceptable performance was demonstrated for all organisms tested.

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Table 1. Organism recovery results

| Organism | Hold Temperature | Average CFU/mL Recovered: Time 0 hrs | Average CFU/mL Recovered: Time 48 hrs | T=48 hrs Log reduction (-) Log increase (+) |
| --- | --- | --- | --- | --- |
| Escherichia coli (ATCC 25922) | 2-8°C | 7.0 X 103 | 4.0 X 103 | -0.39 |
| | 20-25°C | 6.9 X 103 | 3.7 X 103 | -0.27 |
| Enterococcus faecalis (ATCC 29212) | 2-8°C | 6.9 X 103 | 6.5 X 103 | -0.03 |
| | 20-25°C | 6.0 X 102 | 2.8 X 103 | 0.56 |
| Proteus mirabilis (ATCC 7002) | 2-8°C | 2.0 X 103 | 1.5 X 103 | -0.11 |
| | 20-25°C | 2.0 X 103 | 1.4 X 103 | -0.14 |
| Pseudomonas aeruginosa (ATCC BAA-427) | 2-8°C | 6.3 X 103 | 4.8 X 103 | -0.11 |
| | 20-25°C* | 6.5 X 102 | 2.4 X 102 | -0.44 |
| Staphylococcus saprophyticus (ATCC 15305) | 2-8°C | 6.1 X 103 | 2.6 X 103 | -0.38 |
| | 20-25°C | 6.2 X 103 | 3.7 X 103 | -0.23 |
| Enterobacter cloacae (ATCC 13047) | 2-8°C | 1.0 X 103 | 3.4 X 102 | -0.49 |
| | 20-25°C | 1.3 X 104 | 2.4 X 103 | -0.73 |
| Klebsiella pneumonia (ATCC 13883) | 2-8°C | 6.4 X 103 | 5.2 X 103 | -0.09 |
| | 20-25°C | 7.0 X 103 | 5.9 X 103 | -0.08 |
| Streptococcus agalactiae (ATCC 13813) | 2-8°C | 7.9 X 103 | 4.4 X 103 | -0.25 |
| | 20-25°C | 7.1 X 103 | 4.9 X 103 | -0.16 |
| Candida albicans (ATCC 24433) | 2-8°C | 1.9 X 103 | 7.4 X 102 | -0.43 |
| | 20-25°C | 1.8 X 103 | 3.0 X 102 | -0.78 |
| Candida glabrata (ATCC 2001) | 2-8°C | 3.5 X 103 | 1.6 X 103 | -0.34 |
| | 20-25°C | 4.2 X 104 | 1.6 X 104 | -0.44 |
| 0.5 McFarland microorganism suspension was diluted and spiked into clinically negative urine. 100μL of spiked urine was plated on each plate for the 0hrs time point. *200μL of spiked urine was plated on each plate for the 0hr time point. | | | | |

a. Precision/Reproducibility:

Not Applicable

b. Linearity/assay reportable range:

Not Applicable

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c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Shelf life: The shelf life for the Greiner Vacuette Urine CCM tube is 14 months after the date of manufacture. The stability of the vacuum tubes was performed on a total of five lots of Greiner Vacuette Urine CCM tubes. Tube vacuum stability was done in real time. At time point zero, four tubes from each lot were averaged together to ensure that they met (or did not exceed by more than 10%) the predetermined fill volume (10 mL, 5 mL or 4 mL). The rest of the lot was kept at room temperature and periodically tested at one, three, six, nine, 12, 14, and 20 months. At each time point 25 tubes per lot were tested for vacuum fill volume. Tubes were demonstrated to have enough vacuum to autofill within 10% of the deigned fill volume for each of the three sizes and for all the time points out to 14 months.

Sterilization: The Greiner Vacuette Urine CCM tubes are sold as sterile by e-beam irradiation. Irradiation was set at 16.6 KG. Bioburden testing was conducted on expired vials. The 14 month sterility claim was supported based on data demonstrating no growth detected up to this period.

d. Detection limit:

Not Applicable

e. Analytical specificity:

Not Applicable

f. Assay cut-off:

Not Applicable

2. Comparison studies:

a. Method comparison with predicate device:

Method comparison is not applicable for a bacterial transport medium. The device itself does not provide a result that can be used in making a clinical decision. Bench testing studies were done to determine the ability of the Greiner Vacuette Urine CCM tube to maintain viability of microorganisms commonly found as the etiological agents of urinary tract infections. The microorganisms were spiked into filter sterilized pooled urine for testing. The Greiner Vacuette Urine CCM tube showed recovery of representative bacteria from pooled urine within the acceptance criteria recommended in CLSI-M40-A2. (See section M.1. above).

b. Matrix comparison:

Not Applicable

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3. Clinical studies:
a. Clinical Sensitivity:
Not Applicable
b. Clinical specificity:
Not Applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not Applicable

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
Not Applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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