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

Device Description

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided document for the SERIM™ Blood Leak Test Strips-2:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Sensitivity: Positive reading for 1.5 mg/dL hemoglobin (corresponding to approximately 0.1 mL/minute blood loss, well below AAMI recommended limit of 0.35 mL/minute or 5.5 mg/dL hemoglobin)	100% Sensitivity: Sixty positive strip readings were obtained with dialysis buffer containing non-hemolyzed blood at 1.5 mg/dL hemoglobin (as determined by the cyanmethemoglobin method).
Specificity: Negative reading for dialysate without significant blood.	100% Specificity: Sixty negative strip readings were obtained with dialysis buffer without blood.
Clear distinction between Positive and Negative color blocks.	Two color blocks on the bottle label (yellow for Negative, green for Positive) provide a clear distinction.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 60 negative samples and 60 positive samples (totaling 120 samples).
Data Provenance: The document does not specify the country of origin. The data appears to be from a controlled laboratory study, not directly referenced as prospective or retrospective patient data. It describes "blind studies" using "blood standards" in "dialysis buffer."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts or their qualifications for establishing the ground truth. It states that positive ground truth was defined as "1.5 mg/dL hemoglobin, determined by the cyanmethemoglobin method." This implies reliance on a laboratory assay rather than human expert interpretation for the quantitative ground truth. The color block comparison is manual, but the underlying "true" hemoglobin levels were determined by a standard analytical method.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method. The test strips are designed for visual comparison to distinct positive and negative color blocks. The 100% sensitivity and specificity reported suggest no ambiguity in interpretation for the tested samples, implying direct comparison to the color blocks was sufficient, without needing further adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the standalone performance of the device and its comparison to a predicate device's chemical properties. The document does not discuss human reader performance, either with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was conducted. The "SERIM Blood Leak Test Strips-2" themselves are a standalone diagnostic device. The reported sensitivity and specificity demonstrate the performance of the device independent of human interpretation ambiguity, beyond simply visual classification after the test is run. The device is the "algorithm" in this context (chemical reaction leading to a visual output).

7. Type of Ground Truth Used

The ground truth for positive samples was established using a quantitative laboratory method: "1.5 mg/dL hemoglobin, determined by the cyanmethemoglobin method."
The ground truth for negative samples was "dialysis buffer without blood."

8. Sample Size for the Training Set

The document does not describe a training set or a machine learning algorithm. This device is a chemical test strip, not an AI-based system. Therefore, the concept of a "training set" is not applicable in this context.

9. How the Ground Truth for the Training Set Was Established

As the device is a chemical test strip and not an AI-based system, there is no "training set," and therefore, no process for establishing its ground truth.

Summary

{0}------------------------------------------------

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 • (219) 264-3440 • FAX (219) 266-6222

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: (219) 264-3440 Fax: (219) 266-6222

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.

{1}------------------------------------------------

Description of the SERIM Blood Leak Test Strip-2

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

{2}------------------------------------------------

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.

{3}------------------------------------------------

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.

{4}------------------------------------------------

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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

{5}------------------------------------------------

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

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

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
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.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.