RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104
Applicant
Reprocessing Products Corp
Product Code
MNV · Gastroenterology, Urology
Decision Date
Jan 7, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5820
Device Class
Class 2
Indications for Use
The Reprocessing Products Corporation Test Strips are intended for use in the monitoring of pH in Dialysate and Water.
Device Story
Semi-quantitative reagent test strips; plastic strip with chemical-impregnated pad. Input: dialysate or water sample. Operation: pad reacts with hydrogen ions in solution, causing color change. Output: visual color change compared against provided color charts. Used in clinical settings for monitoring hemodialysis water and dialysate quality. Healthcare providers interpret color change to verify pH levels, ensuring dialysate/water meets required specifications for hemodialysis procedures. Benefits patient by ensuring proper chemical composition of dialysis fluids.
Clinical Evidence
Bench testing only. Product performance evaluated by comparing color changes against reference solutions of known pH. Data confirms consistent color matching for pH ranges 6.8-8.5 (acid/bicarbonate dialysate, bicarbonate concentrate, water) and 0-14 (water).
Technological Characteristics
Reagent test strip with chemical-impregnated pad on plastic handle. Two variants: 6.8-8.5 pH range and 0-14 pH range. Sensing principle: chemical reaction with hydrogen ions resulting in color change. Visual interpretation via color charts. Standalone device.
Indications for Use
Indicated for determining pH of acid dialysates, bicarbonate dialysates, or water. Specifically, pH 6.8-8.5 range for acid/bicarbonate dialysate, bicarbonate concentrate, and water; pH 0-14 range for water used to prepare dialysate.
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
SERIM® BICARB PH REAGENT STRIPS
Submission Summary (Full Text)
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K101750 Page 1 of 2
# 510(k) SUMMARY
JAN - 7 2011
| Prepared: | December 14, 2010 | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Submitter: | Reprocessing Products Corporation | |
| Address: | 3655 N. Oracle Road<br>Tucson, AZ 85705 | |
| Phone: | 520-888-5551 | |
| Fax: | (Fax) 520-888-5557 | |
| Contact: | Michael Honstein, Chief Operating Officer | |
| Device Trade Name: | Two ranges:<br>0-14 pH Test Strips (K100-0104) and 6.8-<br>8.5 pH Test Strips (K100-0117) | |
| Common or Usual Name: | pH Test Strips | |
| Device Classification Name: | Strip, Test, Reagent, Dialysate, Water | |
| Product Code: | MSY | |
| Class: | II | |
| Regulation Number: | 876.5665 | |
| Substantial Equivalence: | The Reprocessing Products Corporation<br>pH Test Strips are substantially equivalent<br>to the SERIM® BICARB PH REAGENT<br>STRIPS | |
| Device Description: | Device is semi-quantitative, reagent test<br>strip comprised of a pad impregnated with<br>chemicals which change color upon<br>contact with Dialysate or Water<br>respectively. The pad is attached to a<br>plastic strip for handling. | |
| Intended Use: | The Reprocessing Products Corporation<br>Test Strips are intended for use in the<br>monitoring of pH in Dialysate and Water. | |
| Technological Characteristics: | pH test strips are comprised of two<br>different pH ranges: The K100-0117 test<br>Strips will determine the pH in the range<br>of 6.8 -8.5 for acid/bicarbonate dialysate,<br>bicarbonate concentrate and water used to<br>prepare dialysate. The K100-0104 test<br>strips will determine the in the range of 0-<br>14 pH for water used to prepare dialysate.<br>The test strip contains a specialized<br>chemical formulation that reacts with the<br>Hydrogen ion concentration in solutions of<br>dialysate and water. The reaction results in<br>a color change which is correlatable to the<br>concentration of Hydrogen ions in the | |
| | solution.<br>The color change is interpreted by the use<br>of color blocks on two separate (ranges)<br>color charts. Gradations for 6.8-8.5 pH<br>Test Strips (K100-0117) include 6.8, 7.0,<br>7.2, 7.4, 7.6, 7.8, 8.0, and 8.5. Gradations<br>for the 0-14 pH test strips (K100-0104)<br>include 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,<br>12, 13, and 14. | JAN - 7 |
| Performance: | The data confirm that the product<br>consistently generates color changes which<br>match the color blocks for the Reference<br>solution pH. Reference solutions were<br>used to evaluate pH performance between<br>6.8 and 8.5 in acid/bicarbonate dialysate,<br>bicarbonate concentrate and water, and the<br>pH performance between 0 and 14 in water<br>used to prepare dialysate. These data<br>demonstrate appropriate performance for<br>use in hemodialysis dialysate and water. | |
| Conclusion: | The Reprocessing Products Corporation<br>pH test strips have the same intended use<br>as the predicate device. Test strips measure<br>the hydrogen ion concentration in<br>acid/bicarbonate dialysate or water. The<br>Reprocessing Products Corporation pH<br>Test Strips have no characteristics which<br>raise new types of safety and effectiveness<br>questions. The Reprocessing Products<br>Corporation pH Test Strips can be used to<br>monitor the pH (hydrogen ion<br>concentration) present in water and/or<br>dialysate. | |
.
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K101750 Page 2 of 2
2011
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
7 2011 JAN
Reprocessing Products Corp. c/o Mr. Walter B. Jansen MedReg Consulting 8662 Comstock Lane N. . MAPLE GROVE MN 55311-1436
Re: K101750
Trade/Device Name: RPC E-Z CHEK® pH TEST STRIPS Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: MNV Dated: January 5, 2011 Received: January 5, 2011
Dear Mr. Jansen:
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. Please note: CDRH does not evaluate information related to contract liability v warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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.
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); medical device reporting of medical device-related
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Page 2
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default:htm.
Sincerely yours,
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### 4 Statement of Indications for Use:
## Indications for Use
JAN - 7 2011
510(k) Number (if known): K101750
RPC E-Z CHEK® pH TEST STRIPS Device Name: Indications for Use: The Reprocessing Product Corporation (RPC) pH Test Strips are indicated for determining the pH of acid dialysates, bicarbonate dialysates, or water. These Test Strips are indicated for testing acid/bicarbonate dialysates and water.
- pH Test Strips are comprised of two different pH . ranges:
- . pH = 6.8-8.5 (K100-0117) is for acid/bicarbonate dialysate, bicarbonate concentrate and water
- pH = 0-14 (K100-0104) is for water used to . make up dialysate.
Prescription Use X AND/OR Over the Counter Use (Part 21 CFR 801 Subpart D) (21CFR 801 Subpart C)
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
form m Nha
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K101756
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Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
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Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
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With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
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Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
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What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
