SERIM HISENSE ULTRA 0.1, PART NUMBER 5167

K080712 · Serim Research Corp. · MSY · May 6, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K080712
• Device Name: SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
• Applicant: Serim Research Corp.
• Product Code: MSY · Gastroenterology, Urology
• Decision Date: May 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

SERIM® HiSENSE ULTRA 0.1 TM Test Strips provide a convenient means for indicating the concentration of residual chlorine (chlorine bleach) detected in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment. HiSENSE ULTRA 0.1 also provides a quick and convenient means for indicating low levels of total chlorine (chloramines/free chlorine) in water used to prepare dialysate.

Device Story

Single-use, semi-quantitative reagent test strip; 0.20-inch square reagent pad on 3.25-inch opaque polystyrene strip. Detects total chlorine (free chlorine/chloramines) in water samples. Chemical reaction between chlorine and indicators (potassium iodide, surfactants) produces blue-purple color complex. Intensity of color correlates to chlorine concentration (0-3 ppm range; 0.1 ppm sensitivity). Used by clinical staff in hemodialysis facilities to verify water quality for dialysate preparation and confirm removal of chlorine bleach from equipment rinse lines. Visual comparison of pad color against label color blocks informs clinical decision-making regarding safety of water for dialysis and adequacy of equipment rinsing.

Clinical Evidence

Bench testing only. Performance evaluated using water samples spiked with sodium hypochlorite or chloramines across a range of total chlorine levels. Device demonstrated reliable detection of 0.1 ppm total chlorine, consistent with predicate performance.

Technological Characteristics

Reagent test strip; polystyrene substrate. Contains indicators, non-ionic surfactant, and potassium iodide. Colorimetric sensing principle; blue-purple complex formation proportional to chlorine concentration. Range: 0-3 ppm; sensitivity: 0.1 ppm. Manual visual readout.

Indications for Use

Indicated for hemodialysis clinical settings to monitor residual chlorine in dialysate rinse lines post-disinfection and to monitor total chlorine levels in water used for dialysate preparation.

Regulatory Classification

Identification

A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

Special Controls

*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• SteriChek Total Chlorine Reagent Strips (K001194)

Submission Summary (Full Text)

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SERIM Research Corporation 510(k) Premarket Notification Serim® HiSENSE ULTRA 0.1™ Test for Total Chlorine

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MAY - 6 2008

# 510 (K) SUMMARY

March 11, 2008 Prepared:

Serim Research Corporation Submitter: P.O. Box 4002 Address Elkhart IN 46514

> 574-264-3440 Phone: [phone] Fax:

Patricia A. Rupchock Contact: Director of Regulatory Affairs

Strips: K001194

Total Chlorine Reagent Strips

SERIM® HISENSE ULTRA 0.1TM Device Trade Name:

Common or Usual Name:

Device Classification Name:

Strip, Test, Reagent, Residuals for Dialysate, Disinfectant

The SERIM® HiSENSE ULTRA 0.1™ is substantially

equivalent to Sterichek Sensitive Total Chlorine Reagent

Product Code: MSY

> Class: II

Regulation Number: 876.5665

Substantial Equivalence:

Device Description:

The device is a semi-quantitative or qualitative, single use, reagent test strip made up of a 0.20 inch square reagent pad that has been chemically treated to detect total chlorine (free chlorine/chloramines) in water. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.

Intended Use:

SERIM® HiSENSE ULTRA 0.1™ Test Strips provide a convenient means for indicating the concentration of residual chlorine (chlorine bleach) detected in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment. HiSENSE ULTRA 0.1 also provides a quick and convenient means for indicating low levels of total chlorine (chloramines/free chlorine) in water used to prepare dialysate.

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K080712
CONFIDENTIAL 2 of 2

#### Technological Characteristics:

The SERIM® HiSENSE ULTRA 0.1™ Test Strips contain two indicators, a non-ionic surfactant, potassium iodide, and other inactive ingredients. Total chlorine (free chlorine/chloramines) reacts with the indicators to form a blue-purple complex. The amount of blue-purple color formed is dependent on the concentration of total chlorine in the sample. The color blocks on the label are related to chlorine concentration in terms of parts per million (ppm). The device is used to detect total chlorine concentrations between 0 and 3 ppm. The device will reliably detect concentrations of 0.1 ppm total chlorine.

Performance:

The performance of the Serim HiSENSE ULTRA 0.1 Test Strips were evaluated using water samples in which either sodium hypochlorite or chloramines were added to give a range of total chlorine (free chlorine/chloramines) levels. The performance of the Serim HiSENSE ULTRA 0.1 Test Strips is substantially equivalent to the predicate device, SteriChek Total Chlorine Reagent Strips.

Conclusion:

The Serim HiSENSE ULTRA 0.1 Test Strips have the same intended use as the predicate device. Both test strips measure the total chlorine (free chlorine/chloramines) levels in water. The Serim HiSENSE ULTRA 0.1 Test Strips have no characteristics that raise new types of safety or effectiveness questions. The Serim HiSENSE ULTRA 0.1 Test Strips can be used to monitor the level of total chlorine (free chlorine/chloramines) that may be present in water used to prepare dialysate. The test strips can also be used to detect residual chlorine levels in rinse water from dialysis equipment which had been disinfected with chlorine bleach.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines representing wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**MAY - 6 2008**

Ms. Patricia Rupchock Director of Regulatory Affairs Serim Research Corporation 3506 Reedy Drive ELKHART IN 46561

Re: K080712

> Trade/Device Name: Serim® HiSENSE ULTRA 0.1" Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: MSY Dated: March 11, 2008 Received: March 13, 2008

Dear Ms. Runchock:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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**K080712**
CONFIDENTIAL

SERIM Research Corporation 510(k) Premarket Notification Serim® HiSENSE ULTRA 0.1TM Test for Total Chlorine

## INDICATIONS FOR USE

#### 510(k) Number (if known):

K080712

Device Name:

### Serim® HiSENSE ULTRA 0.1TM

:

Indications For Use: SERIM® HiSENSE ULTRA 0.1 TM Test Strips provide a convenient means for indicating the concentration of residual chlorine (chlorine bleach) detected in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment. HiSENSE ULTRA 0.1 also provides a quick and convenient means for indicating low levels of total chlorine (chloramines/free chlorine) in water used to prepare dialysate.

Prescription Use (Part 21 CFR 801 Subpart D) AND / OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

> Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off (Division Sigil-On)
> Division of Reproductive, Abdominal,

Division of P.H.P.
and Radiological Devices
510(k) Number K080