← Product Code [SFO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/SFO) · K243965 # Origin™ (K243965) _Nerv Technology Inc. (D.B.A.) Fluidai Medical · SFO · Aug 21, 2025 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/SFO/K243965 ## Device Facts - **Applicant:** Nerv Technology Inc. (D.B.A.) Fluidai Medical - **Product Code:** [SFO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/SFO.md) - **Decision Date:** Aug 21, 2025 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1120 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The Origin™ system is comprised of the Origin™ inline device and Origin™ App. The Origin™ system is indicated for use in conjunction with a compatible drainage system by a trained healthcare professional during postoperative recovery in a hospital setting. The Origin™ inline device is placed between the surgical drainage catheter and reservoir system to continuously measure the pH of drainage fluid to provide additional information on effluent characteristics. The device is not intended to diagnose or treat any clinical condition. ## Device Story Origin™ is an inline biosensor system for continuous monitoring of wound drainage pH. The device integrates between a surgical drainage catheter and a reservoir system. It utilizes an Ion-Sensitive Field Effect Transistor (ISFET) and an Ag/AgCl reference electrode to perform potentiometric measurements of hydrogen ion activity. The system includes an inline device, calibration syringes, and an Android tablet running the Origin™ App. The app performs real-time temperature compensation of pH readings and displays data to the clinician. The device is intended for use by trained healthcare professionals in hospital settings during postoperative recovery. It provides continuous effluent characteristic information; however, it is not intended for diagnostic or treatment decisions. The device requires daily calibration using NIST-traceable fluids. The system is designed for a 5-day duration of use. ## Clinical Evidence No clinical data. Performance supported by bench testing. Precision evaluated using clinical peritoneal fluid (N=1440 per sample) with total within-laboratory CVs of 1.46% (pH 6.3) and 2.10% (pH 7.8). Reproducibility assessed over 5 days with continuous sampling (N=17,248-17,257) showing average CVs <0.62%. Linearity confirmed in pH 4-10 range (max deviation 0.1 pH units). Interference testing with 16 endogenous/exogenous agents showed no significant interference. Method comparison against a glass pH probe using 60 human peritoneal drainage samples demonstrated performance across pH 5-9. ## Technological Characteristics Potentiometric pH measurement using an Ion-sensitive field-effect transistor (ISFET) and Ag/AgCl reference electrode. Measurement range: 5-9 pH. Resolution: 0.01 pH. Connectivity: Bluetooth to Android mobile device. Power: Battery-powered. Calibration: 1-point liquid calibration. Standards: IEC 62304, IEC 60601-1, IEC 60601-1-2, IEC 61010-1, IEC 61326-2-6. ## Regulatory Identification A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances. ## Predicate Devices - ABL835 Flex Analyzer ([K013488](/device/K013488.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT ## I Background Information: A 510(k) Number K243965 B Applicant NERv Technology Inc. D.B.A. FluidAI Medical C Proprietary and Established Names Origin™ D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | SFO | Class II | 21 CFR 862.1120 - Blood Gases (PCO2, PO2) And Blood pH Test System. | CH - Clinical Chemistry | ## II Submission/Device Overview: A Purpose for Submission: New device B Measurand: pH C Type of Test: Quantitative Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. B Indication(s) for Use: The Origin™ system is comprised of the Origin™ inline device and Origin™ App. The Origin™ system is indicated for use in conjunction with a compatible drainage system by a trained healthcare professional during postoperative recovery in a hospital setting. The Origin™ inline device is placed between the surgical drainage catheter and reservoir system to continuously measure the pH of drainage fluid to provide additional information on effluent characteristics. The device is not intended to diagnose or treat any clinical condition. C Special Conditions for Use Statement(s): Rx - For Prescription Use Only Origin™ has not been validated to aid in the diagnosis of disease conditions such as anastomotic leaks, ischemia, fistula, infection, sepsis, esophageal ruptures, congestive heart failure, tuberculosis, rheumatoid disease, pneumonia, and/or malignant disease. Do not use data provided by Origin™ to make a clinical decision or drive treatment or diagnosis. Doing so may cause serious harm to the patient. The effects of Origin™ on downstream laboratory testing of drainage fluid have not been evaluated. It is recommended that sample fluid is collected prior to Origin™ attachment and/or prior to fluid passing through Origin™ for downstream laboratory testing. D Special Instrument Requirements: Origin™ (Inline Device) and Origin™ App IV Device/System Characteristics: A Device Description: Origin™ is an inline biosensor system that is integrated between an off-the-shelf drainage catheter and reservoir system and is designed to monitor real-time changes in drained effluent characteristics. Origin™ continuously monitors the pH of wound drainage. The Origin™ device comprises the following major components and accessories: Inlet Nozzle, Outlet Nozzle, Short Flexible Tubing, Long Flexible Tubing, Power Button, 3-way Stopcock, Status Light indicator, Reservoir Ring, Loop Ring, Tube Clamp, and safety pin. Internal components of Origin™ include electronic circuitry, batteries, and a flow cell with the pH sensor module. Other equipment necessary for the proper use of Origin™ include: K243965 - Page 2 of 9 {2} - Calibration syringes: a set of three syringes per daily calibration, prefilled with calibrators used to calibrate and verify Origin™ sensors and ensure the accuracy of measurements. - Origin™ software application: an application that is pre-installed on a compatible Android mobile tablet provided by FluidAI Medical And is used to interact with Origin™ and view patient data. The claimed duration of device use is 5 days. ## B Principle of Operation: Origin™ measures the pH of drainage fluid by measuring the voltage difference (potentiometric) between a reference electrode (Ag/AgCl) and an Ion-Sensitive Field Effect Transistor (ISFET). An ISFET is made from a semiconducting material that is sensitive to hydrogen ions in a solution, and it measures the pH by directly measuring the activity of the $\mathrm{H}_3\mathrm{O}^+$ ion, where “a” represents the hydrogen ion activity in the equation below. $$ pH = - \log a_{H_3O^+} $$ The ISFET changes its surface potential in proportion to the pH of the solutions it is exposed to. This change in surface potential is measured differentially against a stable reference potential, from the reference electrode, and can be converted to a pH reading by the following equation: $$ pH_{\text{unknown solution}} = \frac{E_{\text{unknown solution}} - E_{\text{standard A}}}{\text{Sensitivity}_{\text{ISFET}}} $$ Origin™ measures and automatically compensates for the actual temperature of the drainage fluid in its flow cell in real-time. The Origin™ App calculates the temperature corrected pH and displays it by default using the following equation: $$ pH_{\text{temperature corrected}} = pH_{\text{uncorrected}} \times \frac{\text{Fluid temperature}_{\text{at point of measurement}}}{\text{Fluid temperature}_{\text{at point of calibration}}} $$ ## C Instrument Description Information: 1. Instrument Name: Origin™ 2. Specimen Identification: Not applicable. 3. Specimen Sampling and Handling: Not applicable. 4. Calibration: Origin™ must be calibrated at the following times: K243965 - Page 3 of 9 {3} - After initial attachment of Origin™ inline device to the patient’s drain system. - Every 24 hours (at minimum) thereafter Calibration should be performed with calibration syringes provided by the sponsor, which are pre-filled with NIST-traceable calibration fluids. 5. Quality Control: Each calibration includes a syringe with verification fluid, which is used for verification of the Origin™ pH sensor. V Substantial Equivalence Information: A Predicate Device Name(s): ABL835 FLEX analyzer B Predicate 510(k) Number(s): K110416 C Comparison with Predicate(s): | Device & Predicate Device(s): | K243965 | K110416 | | --- | --- | --- | | Device Trade Name | Origin™ | ABL835 FLEX analyzer | | General Device Characteristic Similarities | | | | Intended Use/Indications For Use | Measurement of pH | Same | | Measurement Principle | Potentiometric measurement of pH | Same | | Reference Electrode | Ag/AgCl | Same | | General Device Characteristic Differences | | | | Measurement range | pH 5-9 | pH 7-7.5 | | pH Electrode | Ion-sensitive field-effect transistor (ISFET) | Glass ion-sensitive electrode (ISE) | | Sample type | Drain effluent | Pleural fluid or blood | | Sample frequency | Continuous | Discrete | | Calibration method | 1 point liquid calibration | 2-point liquid calibration | K243965 - Page 4 of 9 {4} VI Standards/Guidance Documents Referenced: - Clinical and Laboratory Standards Institute (CLSI) EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures - CLSI EP06: Evaluation of Linearity of Quantitative Measurement Procedures-2nd Edition - CLSI EP07: Interference Testing in Clinical Chemistry - 3rd Edition - IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION: Medical device software — Software life cycle processes - IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION: Basic Safety and Essential Performance of Electrical Medical Equipment and Electrical Medical Systems - IEC 61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION: Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements - IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION: Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests - IEC 61326-2-6 Edition 3.0 2020-10: Electrical Equipment for Measurement, Control and Laboratory Use - EMC Requirements - Part 2-6: Particular Requirements - In Vitro Diagnostic (IVD) Medical Equipment - CLSI EP37 1st Edition: Supplemental Tables for Interference Testing in Clinical Chemistry - CLSI EP39 1st Edition: A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests VII Performance Characteristics (if/when applicable): A Analytical Performance: 1. Precision/Reproducibility: Repeatability Study A study was conducted to evaluate the within-run (repeatability), between-run, between-day, between-device, and within-laboratory (total) precision of the Origin device when exposed to clinical peritoneal drainage fluid samples over its 5-day intended use period. The study was conducted using clinical peritoneal fluid at two pH levels (about 6.3 and 7.7). A total of 16 Origin devices were tested across two independent experimental sets by 4 operators. 3 runs were conducted per day (post-calibration, mid-day, pre-calibration the following day). | Sample | N | Mean value | Repeatability | | Between-Run | | Between-Day | | Between-Device | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | A | 1440 | 6.303 | 0.0154 | 0.24% | 0.0384 | 0.61% | 0.0758 | 1.20% | 0.0323 | 0.51% | 0.0922 | 1.46% | | B | 1440 | 7.854 | 0.0190 | 0.24% | 0.1426 | 1.82% | 0.0809 | 1.03% | 0.0000 | 0.00% | 0.1650 | 2.10% | K243965 - Page 5 of 9 {5} Reproducibility Study A study was conducted to evaluate the inter-device variability and reproducibility of Origin™. 10 Origin™ devices were included in this study, split between two, 5-device systems. Aqueous pH 6 and 8 buffers were fed through systems 1 and 2, respectively, using a gravity drip bag at various flow rates for five consecutive 24-hour periods. Measurements were taken continuously at a sampling rate of 25 seconds. To demonstrate reproducibility and inter-device variability between devices, the collected data's CV (%) were calculated for every 25 second measurement available per system, per 24-hour period, across the 5 devices in each system. | Sample | Measurement | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Overall | | --- | --- | --- | --- | --- | --- | --- | --- | | System 1 (pH 6) | N | 3434 | 3449 | 3456 | 3456 | 3453 | 17248 | | | Mean pH | 5.9894 | 6.0548 | 6.0398 | 6.0449 | 6.0465 | 6.0351 | | | Average %CV | 1.1792 | 0.5162 | 0.4509 | 0.4101 | 0.4126 | 0.5931 | | System 2 (pH 8) | N | 3456 | 3457 | 3456 | 3454 | 3434 | 17257 | | | Mean pH | 8.0712 | 8.0365 | 8.0343 | 8.0349 | 8.0372 | 8.0428 | | | Average %CV | 1.9392 | 0.3013 | 0.2392 | 0.2967 | 0.3080 | 0.6173 | 2. Linearity: A linearity study using NIST traceable pH buffer solutions in the range of pH 4-10 was conducted. The maximum deviation of linearity was 0.1 pH units. Data from the Method Comparison study was also used to support the linearity of Origin™. A maximum deviation from linearity of 0.1446 pH units was observed. 3. Analytical Specificity/Interference: An interference study was conducted to determine if Origin™ produces accurate and reliable results in the presence of 16 common endogenous and exogenous agents present in the intended patient population. In the study, the effect of each interferent on the pH measurements of Origin™ was measured through a paired difference test. This test occurred across two pH levels (pH 7 – Low and pH 8 – High) using commercially available simulated peritoneal fluids. 16 paired observations were obtained per pH level for each interferent. No significant source of interference was determined from the testing of spiked simulated peritoneal fluids. | Interferent | Concentration (mg/dL, base mass) | Interferent Type | | --- | --- | --- | | Bilirubin | 60 | Endogenous | | Triglycerides | 1667 | Endogenous | | Creatinine | 75 | Endogenous | | Albumin (or total protein) | 5300 | Endogenous | K243965 - Page 6 of 9 {6} | Interferent | Concentration (mg/dL, base mass) | Interferent Type | | --- | --- | --- | | Uric acid | 31.2 | Endogenous | | Glucose | 1000 | Endogenous | | Hemoglobin | 1000 | Endogenous | | Morphine | 0.78 | Exogenous | | Acetaminophen | 7.8 | Exogenous | | Ibuprofen | 36 | Exogenous | | Celecoxib | 2.4 | Exogenous | | Ondansetron | 0.0342 | Exogenous | | Cefoxitin | 92.7 | Exogenous | | Metronidazole | 12.3 | Exogenous | | Bupivacaine | 1.05 | Exogenous | | Heparin | 330 units/dL | Exogenous | The effects of Origin™ on downstream laboratory testing of drainage fluid have not been evaluated. It is recommended that sample fluid is collected prior to Origin™ attachment and/or prior to fluid passing through Origin™ for downstream laboratory testing. 4. Assay Reportable Range: The reportable range is pH 5-9. 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods): The Origin™ device is traceable to NIST standards. 6. Detection Limit: The measuring range of the Origin device is pH 5 to 9. 7. Assay Cut-Off: Not applicable. 8. Accuracy (Instrument): See Method Comparison section VII.B.1. below. 9. Carry-Over: Not applicable. K243965 - Page 7 of 9 {7} K243965 - Page 8 of 9 ## B Comparison Studies: 1. **Method Comparison with Predicate Device:** Origin™ was compared against a glass pH probe when measuring 60 donor human peritoneal drainage fluid samples. The study was conducted over 6 days with 8 Origin™ devices. The measurements used in the evaluation were taken at the end of a 24-hour calibration period for Origin™ to represent the worst-case scenario bias. | pH range | Slope [95% CI] | Intercept [95% CI] | r² | Mean bias [95% CI] | | --- | --- | --- | --- | --- | | 5-6 | 0.961 [0.770, 1.151] | -0.001 [-1.073, 1.071] | 0.944 | -0.223 [-0.263, -0.177] | | 6-7 | 0.936 [0.761, 1.112] | 0.167 [-0.983, 1.318] | 0.875 | -0.251 [-0.298, -0.207] | | 7-8 | 1.369 [1.161, 1.578] | -2.899 [-4.482, -1.316] | 0.839 | -0.102 [-0.177, -0.022] | | 8-9 | 1.217 [0.914, 1.520] | -1.892 [-4.391, 0.606] | 0.576 | -0.105 [-0.155, -0.052] | 2. **Matrix Comparison:** Not applicable. ## C Clinical Studies: 1. **Clinical Sensitivity:** Not applicable. 2. **Clinical Specificity:** Not applicable. 3. **Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):** Not applicable. ## D Clinical Cut-Off: Not applicable. ## E Expected Values/Reference Range: Not applicable. {8} The labeling indicates that Origin™ has not been validated to aid in the diagnosis of disease conditions such as anastomotic leaks, ischemia, fistula, infection, sepsis, esophageal ruptures, congestive heart failure, tuberculosis, rheumatoid disease, pneumonia, and/or malignant disease. Do not use data provided by Origin™ to make a clinical decision or drive treatment or diagnosis. Doing so may cause serious harm to the patient. F Other Supportive Instrument Performance Characteristics Data: Not applicable. VIII Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. IX Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. K243965 - Page 9 of 9 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/SFO/K243965](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/SFO/K243965) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com