← Product Code [CGX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX) · K040976 # GENCHEM CREATININE REAGENT (K040976) _Genchem, Inc. · CGX · Dec 27, 2004 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K040976 ## Device Facts - **Applicant:** Genchem, Inc. - **Product Code:** [CGX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX.md) - **Decision Date:** Dec 27, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1225 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The GenChem Creatinine Test Reagent System is intended for the quantitative determination of creatinine in serum, plasma and urine on the Beckman SYNCHRON CX3® System and as an aid in the diagnosis of renal impairment and diseases such as chronic glomerulonephritis, diabetic nephropathy, chronic interstitial nephritis and as an indicator of glomerular filtration rate. ## Device Story Reagent kit containing alkaline picrate for quantitative creatinine determination. Operates on Beckman SYNCHRON CX3 System. Principle: Jaffe rate method; creatinine reacts with alkaline picrate to form red complex; rate of absorbance increase at 520 nm measured photometrically. Output: creatinine concentration in serum, plasma, or urine. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing renal impairment and monitoring glomerular filtration rate. Reagent replaces predicate for use on existing CX3 hardware. ## Clinical Evidence Bench testing only. Precision/reproducibility evaluated over 30 days (n=60 per serum sample, n=59-60 per urine sample) per NCCLS EP3-T; total %CV ranged from 0.5% to 9.8%. Linearity assessed per NCCLS EP6-A (r=1.00). Analytical specificity tested for hemoglobin, bilirubin, and lipemia per NCCLS EP7-A with no adverse effects. Clinical comparison study (n=80 serum, n=80 plasma, n=79 urine) against the predicate device demonstrated high correlation (slope 0.991-1.000, R2 0.997-1.000). ## Technological Characteristics Alkaline picrate reagent for colorimetric creatinine determination. Designed for use on the Beckman SYNCHRON CX3® System. Analytical method follows standard colorimetric principles. Compatible with heparin and EDTA anticoagulants. No specific materials of construction or software algorithms described; device is a chemical reagent system. ## Regulatory Identification A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. ## Predicate Devices - Beckman Creatinine Reagent for the CX3 (k915077) ## 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} Page 1 of 6 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE A. 510(k) Number: k040976 B. Purpose For Submission: Premarket Notification 510(k) for GenChem, Inc. intentions to manufacture and market the GenChem Creatinine Reagent Kit. C. Analyte: Creatinine D. Type of Test: Quantitative, Photometric End-Point E. Applicant: GenChem, Inc. F. Proprietary and Established Names: GenChem, Inc., Creatinine Reagent Kit G. Regulatory Information: Regulation section: 1. Regulation section: 21 CFR §862.1225 - Creatinine test system. 2. Classification: Class II 3. Product Code: CGX (creatinine) 4. Panel: 75 (Chemistry) {1} Page 2 of 6 ## H. Intended use(s): 1. Intended use(s) The GenChem Creatinine Test Reagent System is intended for the quantitative determination of creatinine in serum, plasma and urine on the Beckman SYNCHRON CX3 System and as an aid in the diagnosis of renal impairment and diseases such as chronic glomerulonephritis, diabetic nephropathy, and chronic intestinal nephritis as an indicator of glomerular filtration rate. 2. Indication(s) for use: The GenChem Creatinine Test Reagent System is intended for the quantitative determination of creatinine in serum, plasma and urine on the Beckman SYNCHRON CX3 System and as an aid in the diagnosis of renal impairment and diseases such as chronic glomerulonephritis, diabetic nephropathy, and chronic intestinal nephritis as an indicator of glomerular filtration rate. 3. Special condition for use statement(s): For Prescription Use. 4. Special instrument Requirements: Beckman CX3 System. ## I. Device Description: The device is a reagent containing alkaline picrate for the determination of creatinine for optimum system operation on the Beckman SYNCHRON CX3 system. ## J. Substantial Equivalence Information: 1. Predicate device name(s): Beckman Creatinine Reagent for the CX3 2. Predicate K number(s): (k915077) {2} Page 3 of 6 3. Comparison with Predicate: | Device Name | GenChem Creatinine Reagent Kit | Predicate Device Beckman Creatinine | | --- | --- | --- | | 510(k) Number | (k040976) | (k915077) | | Chemical Principle | Jaffe rate method | Jaffe rate method | | Intended Use | For the quantitative determination of creatinine in serum, plasma or urine | For the quantitative determination of creatinine in serum, plasma or urine | | Format | 2 part liquid | 2 part liquid | | Composition | Alkaline picrate | Alkaline picrate | | Linearity | Serum or plasma 0-25 mg/dL Urine 10-400 mg/dL | Serum or plasma 0-25 mg/dL Urine 10-400 mg/dL | | Storage | Room temperature | Room temperature | K. Standard/Guidance Document Referenced (if applicable): Within-Day and Day-to-Day precision was determined according to NCCLS EP5-A. Linearity was performed according to NCCLS EP6-A Guideline. Analytical specificity Determined according to NCCLS EP7-A. L. Test Principle: Creatinine + Picric Acid → Creatinine-Picrate Complex (red) Creatinine from the sample combines with picric acid in the alkaline regent to form a red complex. The rate of increase in absorbance at 520 nm, measured seconds after the sample addition, is proportional to the concentration of creatinine in the sample M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Control sera and urine pools were each assayed twice per day in triplicate on a SYNCHRON CX3 System. Data were collected on ten different days over a thirty day period. {3} Page 4 of 6 Precision of Creatinine Recoveries (mg/dL) | Sample | n | Within Run | | | Total | | | --- | --- | --- | --- | --- | --- | --- | | | | mean | SD | %CV | SD | %CV | | Serum 1 | 60 | 0.5 | 0.05 | 9.8 | 0.05 | 9.8 | | Serum 2 | 60 | 4.0 | 0.02 | 0.5 | 0.02 | 0.5 | | Serum 3 | 60 | 7.4 | 0.03 | 0.5 | 0.05 | 0.7 | | Urine 1 | 59 | 40.3 | 0.41 | 1.0 | 0.56 | 1.4 | | Urine 2 | 60 | 222.9 | 2.29 | 1.0 | 2.79 | 1.3 | ## b. Linearity/assay reportable range: Linearity was performed according to NCCLS Guideline EP6-A. Commercially available linearity standards ranging from 0 to 25.7 mg/dL were analyzed in triplicate on the Beckman CX3 and the results analyzed by the Least Squares method. The results gave a slope of 0.994 with an intercept of -0.05, a standard error of estimate of 0.11 and r² = 1.00 and is shown below. Specimens exceeding these limits should be diluted with normal saline and reanalyzed. Multiply the result by the appropriate dilution factor. | Specimens | Usable Ranges | | | --- | --- | --- | | | Conventional Units | SI Units | | Serum/Plasma | 0.2 to 25 mg/dL | 0.2 - 2210 mmol/L | | Urine | 10 - 400 mg/dL | 0.88 - 35.36 mmol/L | ## c. Traceability (controls, calibrators, or method): Beckman Calibration Standards 1 and 2 for the CX3 system ## d. Detection limit: The sensitivity of this method is 0.2 mg/dL and is documented through the repetitive assay of diluted serum control. The observed sensitivity limit, calculated as three standard deviations of a 21 replicate within run precision study, is 0.01 mg/dL and is below the claimed limit of 0.2 mg/dL. Analyte Limit of Detection Creatinine 0.2 mg/dL ## e. Analytical specificity: Determined according to NCCLS EP7-A. Hemoglobin levels up to 500 mg/dL, Bilirubin levels up to 20 mg/dL, and Lipemia levels up to 1800 mg/dL were tested and did not {4} show any adverse effect on a stock sample with a creatinine level of 1.1 mg/dL. Stock solutions of the substance to be tested were prepared at 20x concentrations and 0.5 ml of this stock was placed in a 10 ml volumetric flask and made up to volume with the base pool. The control stock was prepared similarly but with water as the diluent. Heparin, Lithium Heparin Ammonium Heparin, and EDTA are acceptable anticoagulants. f. Assay cut-off: Not applicable for this type of device. 2. Comparison studies: a. Method comparison with predicate device: Serum and plasma, ranging from 0.4 to 30.4 mg/dL and urine specimens ranging from 12.1 to 400 mg/dL were collected from adult patients and assayed for creatinine on a SYNCHRON CX3 System using GenChem and Beckman creatinine reagents. Results were compared by least squares linear regression and the following statistics were obtained: | VALUE | SERUM | PLASMA | URINE | | --- | --- | --- | --- | | Intercept | 0.0 | 0.05 | -0.3 | | Slope | 0.991 | 0.998 | 1.000 | | R² Value | 0.997 | 0.998 | 1.000 | | N | 80 | 80 | 79 | | Range | 0.4 - 30.4 | 0.4 - 30.4 | 12.1 - 400 mg/dL | b. Matrix Comparison See above method comparison studies. 3. Clinical studies: a. Clinical sensitivity: Clinical studies are not typically submitted for this device type. b. Clinical specificity: Clinical studies are not typically submitted for this device type. {5} Page 6 of 6 c. Other clinical supportive data (when a and b are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: The expected values for creatinine are listed below. Use these ranges only as guides. Each laboratory should establish its own normal ranges. | Specimens | Normal Ranges1. | | | --- | --- | --- | | | Conventional Units | SI Units | | Serum/Plasma | 0.6 - 1.3 mg/dL | 53 - 115 mmol/L | | Urine | 11 - 26 mg/day/kg | 97 - 230 mmol/day/kg | 1. Burtis, C.A., Ashwood, E.R. (eds.). Tietz Textbook of Clinical Chemistry. W.B. Saunders Company. Philadelphia, PA. (1994). N. Conclusion: The submitted material in this premarket notification is complete and supports a substantial equivalence decision. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K040976](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K040976) **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. 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