DIPSTREAK

K974428 · Novamed , Ltd. · JSI · Jul 30, 1998 · Microbiology

Device Facts

• Record ID: K974428
• Device Name: DIPSTREAK
• Applicant: Novamed , Ltd.
• Product Code: JSI · Microbiology
• Decision Date: Jul 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2360
• Device Class: Class 1

Indications for Use

The Novamed, Ltd. DipStreak Urine Culture Device is used for the isolation and enumeration of bacteria in urine.

Device Story

DipStreak is a manual urine culture device consisting of a plastic paddle with back-to-back agar surfaces (CLED and MacConkey) housed in a transparent tube. The device features a ring with elongated prongs at the paddle end. Operation involves dipping prongs into a urine sample; upon re-insertion into the tube, the prongs streak the urine across the agar surfaces. This mechanical action creates a dilution effect, enabling the isolation of single bacterial colonies even from high-concentration samples (up to 10^7 organisms/ml). Used in clinical laboratory settings, the device allows healthcare providers to visually identify and enumerate bacterial growth after 24 hours of incubation at 37°C. The resulting colony patterns and growth rates assist in the identification of urinary tract pathogens, facilitating clinical decision-making regarding infection diagnosis and treatment.

Clinical Evidence

Clinical performance evaluated in two studies (n=522) comparing DipStreak to the predicate device, showing 96.4% agreement at 10^4 CFU/ml and 96.9% at 10^5 CFU/ml. A separate study (n=1000) compared DipStreak to traditional petri dish culture, reporting sensitivity and specificity values above 98.6% for both 10^4 and 10^5 CFU/ml cutoff levels.

Technological Characteristics

Plastic paddle with back-to-back agar surfaces (CLED and MacConkey) housed in a transparent plastic tube. Features a ring with elongated prongs for sample collection and mechanical streaking. Manual operation; no energy source required. Dimensions/form factor: paddle-in-tube. Sterilization: not specified. No software or electronic components.

Indications for Use

Indicated for the isolation and enumeration of bacteria in urine samples to detect pathogenic bacteria at levels from 10^3 to 10^7 CFU/ml.

Regulatory Classification

Identification

A selective culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify certain pathogenic microorganisms. The device contains one or more components that suppress the growth of certain microorganisms while either promoting or not affecting the growth of other microorganisms. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

Predicate Devices

• Savyon Diaslide Urine Culturing Device (K921045)

Submission Summary (Full Text)

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JUL 30 1998
510(k) Summary (Revised)
1974428

1. Name of device: DipStreak Urine Culture Device (K974428)
2. Identification of the predicate device: the Savyon Diaslide Urine Culturing Device (510(k) no. K921045).
3. Description of the device: DipStreak comprises a plastic paddle with two types of agar attached back-to-back, housed in a closed transparent plastic tube. A ring with elongated prongs is attached to the end of the paddle so that there are prongs on each side of the slide. The ends of the prongs are dipped into the urine sample. Upon re-insertion into the plastic tube, the prongs are prevented from moving and the agar surfaces are inoculated with bacteria from the urine sample as the agar-coated paddle passes over the prongs. The result is a series of streaks of decreasing bacterial concentration which permits isolation of single colonies even when the original bacterial population of the sample was as high as $10^{7}$ organisms per milliliter.
4. Intended use: the Novamed, Ltd. DipStreak Urine Culture Device is used for the isolation and enumeration of bacteria in urine.
5. Performance and design specifications: pathogenic bacteria found in urine samples at levels from $10^{3}$ to $10^{7}$ CFU/ml are detected accurately and consistently when using the DipStreak Urine Culture Device. Experimental evidence to support this claim is given in the application in the Precision Study.
6. Performance data: when compared to the predicate device in two studies comprising 522 clinical samples, the DipStreak Urine Culture Device demonstrated overall agreement of $96.4\%$ at the cutoff level of $10^{4}$ CFU/ml and $96.9\%$ at the cutoff level of $10^{5}$ CFU/ml. The DipStreak Urine Culture Device was also compared to traditional petri dish culture in a study of 1000 clinical samples. Sensitivity and specificity values for cutoff levels of $10^{4}$ and $10^{5}$ CFU/ml were all above $98.6\%$. Details of these studies are given in the application.
7. User quality control: quality control tests are performed on each lot of DipStreaks at the time of manufacture. Product users who wish to perform their own quality control may use the following procedure.
a. Prepare a suspension $(10^{4} - 10^{5}\mathrm{CFU / ml})$ of each of the following organisms in sterile urine. Confirm the exact organism concentration by inoculating $10~\mu \mathrm{l}$ with a calibrated loop on reference plates of CLED and MacConkey agar.
b. Test the suspension according to the above Procedure.

TYPICAL CULTURE RESPONSE (after 24 hours at $37^{\circ}\mathrm{C}$)

| Strain | Growth rate | Colony Appearance | |
| --- | --- | --- | --- |
| | | MacConkey | CLED |
| E. coli
ATCC No. 25922 | 2-3 mm colonies can be seen within 12-14 hr | Red-purple colonies with smooth borders | Yellow colonies with smooth borders |
| S. aureus
ATCC No. 25923 | MacConkey -no growth
CLED-1 mm colonies can be seen within 12-14 hr | No growth | Yellow colonies with smooth borders |
| P. vulgaris
ATCC No. 13315 | 0.5-1 mm colonies can be seen within 16-20 hr | Colorless colonies with rough borders | Blue colonies with rough borders |

If the device does not support the expected growth of organisms, it has deteriorated and should not be used.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

JUL 30 1998

Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

Gerald M. Slutzky, Ph.D.
Director, Research and Development
Novamed, Ltd.
28 Pierre Koenig St.,
Talpiot Industrial Area
Jerusalem 91531 Israel

Re: K974428
Trade Name: DipStreak Urine Culture Device
Regulatory Class: I
Product Code: JSI
Dated: July 8, 1998
Received: July 13, 1998

Dear Dr. Slutzky:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven I. Gutman, M.D., M.B.A.
Director
Division of Clinical Laboratory Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Page ______ of ______

510(k) Number (if known): K974428

Device Name: *DipStreak Urine Culture Device*

Indications For Use:

The Novamed, Ltd. *DipStreak Urine Culture Device* is used for the isolation and enumeration of bacteria in urine. A set of plastic prongs on the end of the device are dipped into the urine sample. The drops of urine which adhere to the prongs are then streaked across two different agar surfaces (CLED agar on one side, MacConkey agar on the other). A dilution effect takes place which allows the isolation of single colonies.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Debore
(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K974428

Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ☐
(Optional Format 1-2-96)