SERIM BLOOD LEAK TEST STRIP-2

K012115 · Serim Research Corp. · FJD · Nov 30, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012115
• Device Name: SERIM BLOOD LEAK TEST STRIP-2
• Applicant: Serim Research Corp.
• Product Code: FJD · Gastroenterology, Urology
• Decision Date: Nov 30, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Indications for Use

Serim Blood Leak Test Strips – 2 provide a rapid and convenient means for testing dialysate for blood during the conventional hemodialysis procedure or continuous renal replacement therapy procedures such as continuous arteriovenous hemodialysis or continuous venovenous hemodialysis.

Device Story

Device consists of reagent pad on polystyrene handle; used to detect occult blood in hemodialysis fluids. Operator (dialysis technician) immerses pad in dialysate sample; reacts for 60 seconds. Principle: hemoglobin catalyzes oxidation of chromogen by organic peroxide (2,5-dimethylhexane-2,5-dihydroperoxide), producing green color. Output: visual comparison against negative (yellow) and positive (green) color blocks on bottle label. Positive result indicates blood leak (approx. 0.1 mL/min sensitivity); allows confirmation of machine alarms to avoid unnecessary termination of dialysis sessions. Benefits patient by reducing stress associated with false-alarm session interruptions.

Clinical Evidence

Bench testing only. Study compared Serim Blood Leak Test Strips-2 against blood standards in blind studies. Results: 100% specificity (n=60) using dialysis buffer without blood; 100% sensitivity (n=60) using dialysis buffer with 1.5 mg/dL hemoglobin. Performance compared to Chemstrip occult blood test strips, which showed equivalent negative readings and positive readings equal to or greater than 250 erythrocytes/uL for the same samples.

Technological Characteristics

Reagent pad (0.2 x 0.2 inch) on polystyrene handle (0.2 x 3.25 inch). Sensing principle: peroxidase-like activity of hemoglobin catalyzing oxidation of chromogen. Reagents: organic peroxide (2,5-dimethylhexane-2,5-dihydroperoxide) and chromogen. Visual colorimetric readout. Standalone, non-electronic, disposable test strip.

Indications for Use

Indicated for testing dialysate for occult blood during conventional hemodialysis or continuous renal replacement therapy (CRRT) procedures, including continuous arteriovenous or venovenous hemodialysis.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Predicate Devices

• Chemstrip 10 urine test strip (K896454)
• Serim Blood Leak Test Strips-1 (K990206)

Submission Summary (Full Text)

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Page 1/3

NOV 3 0 2001

Image /page/0/Picture/2 description: The image shows a logo for "Serm RESEARCH CORP". The word "Serm" is in a stylized font, with the letters connected and bold. Above the letters is a horizontal line with a small "TM" symbol on the right side. Below the word "Serm" is the text "RESEARCH CORP" in a smaller, sans-serif font.

KOI 2115

P.O. Box 4002, Elkhart, IN 46514-0002 • [phone] • FAX [phone]

# 510(k) SUMMARY

Serim™ Blood Leak Test Strips-2

#### Submitted by:

Robert J. Carrico Serim Research Corporation P.O. Box 4002 Elkhart, IN 46514

Phone: [phone] Fax: [phone]

Contact person: Robert J. Carrico

July 5, 2001 Date prepared:

#### Device Name:

- SERIM™ Blood Leak Test Strips-2 Trade name: Common name: Occult blood test strip
Classification name: Dialysis Blood Leak Test Strip

#### Legally Marketed Equivalent Device:

This product is similar in design, composition and function to the occult blood test pad on Chemstrip 10 urine test strip manufactured by Boehringer Mannheim Corporation which was the subject of Premarket Notification K896454 The product is similar in utility to the cyanomethemoglobin assay. Supportive data for substantial equivalence to the latter was obtained.

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### Description of the SERIM Blood Leak Test Strip-2

The SERIM Blood Leak Test Strips-2 consist of a 0.2 x 0.2 inch reagent pad attached to one end of a white 0.2 x 3.25 inch polystyrene handle. The reagent pad is immersed into a sample, removed immediately and allowed to react for 60 seconds. Then the reagent pad color is compared to two color blocks on the bottle label. One color block marked Negative is yellow with a few green speckles. If a reagent pad has a similar yellow color the dialysate does not contain significant blood. The second color block is green with small yellow speckles and is marked Positive. A reagent pad with green color equal to or darker than this color block indicates the presence of a significant blood leak.

The Association for the Advancement of Medical Instrumentation(AAMI) standards recommends that blood loss be limited to 0.35 mL/minute or less. This calculates to 5.5 mg/dL hemoglobin at 25% hematocrit. (AAMI Standards and Recommended Practices, Vol. 3, 1998, p. 57) SERIM Blood Leak Test Strips-2 are designed to give a positive readings with 1.5 mg/dL hemoglobin in acid/bicarbonate buffer, pH 7.4. Thus, a positive test strip reading corresponds to approximately 0.1 mL/minute blood loss.

Serim Blood Leak Test Strips-2 are similar in function to Serim Blood Leak Test Strips-1, premarket notification no. K990206, currently being marketed to dialysis clinics. The formulation in Serim Blood Leak Test Strips-2 was changed for proprietary reasons. A major change was the replacement of the oxidant diisopropylbenzene dihydroperoxide in Serim Blood Leak Test Strips-1 with 2,5-dimethylhexane-2,5-dihydroperoxide in Serim Blood Leak Test Strips-2.

#### Intended Use:

Hemodialyzers are equipped with photometric sensors in the dialysate stream to detect blood leaks at the dialysis membranes. The sensors measure red color in the dialysate due to hemoglobin in red blood cells. Sensors are calibrated to sound an alarm when blood loss reaches 0.35 mL/minute.

A confirmed blood leak requires termination of the dialysis session and restarting with a new dialyzer. Occasionally false alarms occur possibly due to gas bubbles in the sensor. Since interrupting a dialysis session is stressful for the patient, technicians prefer to confirm an alarm before taking further steps. SERIM Blood Leak Test Strips-2 provide a quick and convenient means to test for occult blood in hemodialysis fluids.

#### Technological Comparison to Predicate Device:

SERIM Blood Leak Test Strips-2 and Chemstrip occult blood test strips both utilize the peroxidase-like activity of hemoglobin to detect whole blood in fluids. Both tests have an organic peroxide and a chromogen dried in test pads. When the pads are exposed to test samples the organic peroxide and chromogen react extremely slowly unless hemoglobin from red blood cells is present. Hemoglobin catalyzes the oxidation of the chromogen to produce green color. The rate of color formation is dependent on the concentration of hemoglobin in the test sample. In some

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applications the level of occult blood in samples is estimated from the amount of color produced. However, a positive/negative answer is preferable in the hemodialysis application. SERIM Blood Leak Test Strips-2 have adequate sensitivity to detect hemoglobin at the required levels as discussed above. Two color blocks used in the test provide a clear distinction between Positive and Negative readings. If a reading between the two blocks is obtained a very small leak may be present and dialysis can be continued because the leak can seal.

#### Statement of Substantial Equivalence

SERIM Blood Leak Test Strips-2 from three production lots were used to test blood standards in blind studies. Sixty negative strip readings (100% specificity) were obtained with dialysis buffer without blood. Chemstrip test strips for occult blood also gave negative readings for these samples. Sixty positive strip readings (100% sensitivity) were obtained with dialysis buffer containing non-hemolyzed blood at 1.5 mg/dL hemoglobin, determined by the cyanmethemoglobin method. Chemstrip test strips for occult blood gave readings equal to or greater than 250 erythrocytes/uL for all of the samples with 1.5 mg/dL hemoglobin.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with stylized wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### NOV 3 0 2001

Ms. Patricia Rupchock Manager of Regulatory Affairs Serim™ Research Corporation P.O. Box 4002 ELKHART IN 46514-0002

Re: K012115 Trade/Device Name: Serim™ Blood Leak Test Strips - 2 Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FJD Dated: October 4, 2001 Received: October 9, 2001

Dear Ms. Rupchock:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) premier is substantially equivalent (for the indications felerenced above and nave decembers and marketed predicate devices marketed in interstate for use stated in the enorosals) to regars) and entirent date of the Medical Device Amendments, or to commerce proof to May 26, 1976, the encordance with the provisions of the Federal Food, Drug, devices mat nave been rocussions in avere approval of a premarket approval application (PMA). alle Costience Act (Tec) that to not required to the general controls provisions of the Act. The Tou may, therefore, thanket the act include requirements for annual registration, listing of general controls provisions of ractice, 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 additional controls. Existing major regulations affecting your device can be it may of Subject to additions, 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 I lease be advised that I Dris issual.reat your device complies with other requirements of the Act that IDA has made a decornmancia as administered by other Federal agencies. You must of any I cocrar statures and rogulations and limited to: registration and listing compry while he rece requirements, at 801); good manufacturing practice requirements as set (21 CFR Part 607), laborning (21 CFR Part 820); and if applicable, the electronic fordrin in the quant) by sections (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C Brogdon

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

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Serim Blood Leak Test Strip - 2 Device Name:

#### Indications For Use:

Serim Blood Leak Test Strips – 2 provide a rapid and convenient means for testing dialysate for Schill Dlood Leak Fest Strips - = provised during the conventional hemodialysis procedure or continuous renal replacement therapy procedures such as continuous arteriovenous hemodialysis or continuous venovenous hemodialysis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|----|--------------------------------------------------|
|------------------------------------------|----|--------------------------------------------------|

| Division Sign-Off | <i>Nancy C. Brogdon</i> |
|---------------------------------------------------------------|-------------------------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K012115 |