Who is the manufacturer of COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2?

Roche Diagnostics filed the 510(k) submission for COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 (K132418).

What is the FDA product code for COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2?

JGS. It is classified under 21 CFR 862.1665 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2

Q: What are the predicate devices for COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2?

cobas c 501 ISE Indirect Na, K, Cl for Gen. 2 (k053165).

K132418 · Roche Diagnostics · JGS · Dec 18, 2013 · Clinical Chemistry

Device Facts

Record ID	K132418
Device Name	COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
Applicant	Roche Diagnostics
Product Code	JGS · Clinical Chemistry
Decision Date	Dec 18, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1665
Device Class	Class 2

Intended Use

The ISE module of the Roche / Hitachi systems is intended for the quantitative determination of sodium, potassium, and chloride in serum, plasma, or urine using ion-selective electrodes. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Device Story

The cobas c 501 ISE module is an automated clinical chemistry analyzer component for measuring sodium, potassium, and chloride ions in serum, plasma, or urine. It utilizes ion-selective electrode (ISE) potentiometry; membrane materials develop an electrical potential (EMF) proportional to ion concentration differences between the test sample and an internal filling solution. The device follows the Nernst equation to calculate ion concentrations. This modification updates the calibration scheme, replacing a serum-based ISE compensator with ISE Standard High (S3) for 2-point calibration and compensation. The system is operated by laboratory professionals in clinical settings. Output is provided as quantitative ion concentration values, which clinicians use to diagnose and monitor metabolic and electrolyte disorders. The modification maintains the same measurement principle and clinical utility as the predicate, providing equivalent diagnostic information for patient management.

Clinical Evidence

Bench testing only. Precision (repeatability and intermediate precision) and method comparison studies were conducted. Method comparison against reference methods (flame photometry for Na/K, coulometry for Cl) showed high correlation (r ≥ 0.998) and slope/intercept values indicating equivalence. LoB, LoD, and LoQ were determined for the modified calibration. No clinical prospective or retrospective studies were required.

Technological Characteristics

Ion-selective electrode (ISE) potentiometry; utilizes selective membranes to generate EMF based on Nernst equation. Integrated into cobas c 501 analyzer. Reagents stored in plastic bottles at 5-12 °C. Calibration uses aqueous ISE Standards (Low and High).

Indications for Use

Indicated for quantitative determination of sodium, potassium, and chloride in serum, plasma, or urine. Used for diagnosis/treatment of electrolyte imbalances, aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate ADH secretion, cystic fibrosis, and diabetic acidosis.

Regulatory Classification

Identification

A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Predicate Devices

cobas c 501 ISE Indirect Na, K, Cl for Gen. 2 (k053165)

Related Devices

K123726 — COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 · Roche Diagnostics · May 21, 2013
K140373 — ISE INDIRECT NA, K, C1 FOR GEN 2 · Roche Diagnostics · May 22, 2014
K230890 — ISE Electrodes · Randox Laboratories, Ltd. · Sep 8, 2023
K053165 — ISE INDIRECT NA, K, CL FOR GEN.2 · Roche Diagnostics Corp. · Dec 14, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ ### 510(k) Summary: 510(k) for the cobas c 501 ISE, Modified Calibration DEC 1 8 2013 Introduction The information in this 510(k) summary is being submitted in accordance with requirements of 21 CFR 807.92. cobas c 501 ISE Indirect Na, K, Cl for Gen. 2. k053165 Submitter name, address, and contact Contact Person: Khoa Tran Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 Phone: (317) -521-3409 Fax: (317) -521-2324 Email: khoa.tran@roche.com Proprietary name: Date Prepared: October 17, 2013 ISE Indirect Na, K, Cl for Gen.2 Device name Common name: Sodium Test System Potassium Test System Chloride Test System Classification: Ion-Specific Electrode Sodium Ion-Specific Electrode Potassium Ion-Specific Electrode Chloride Predicate Device Establishment registration For the cobas c 501 ISE module, the establishment registration number for Roche Diagnostics GmbH in Mannheim, Germany is 9610126. The establishment registration number for Roche Diagnostics, United States is 1823260. {1}------------------------------------------------ ### Classification The FDA has classified the Sodium, Potassium, and Chloride Test Systems as Class II devices. | Panel | Product Code | Classification Name | Regulation | |----------------------------|-----------------|--------------------------------------|--------------------| | Clinical Chemistry (75) | JGS | Ion Specific Electrode, Sodium | 21 CFR 862.1665 | | Clinical Chemistry (75) | CEM | Ion Specific Electrode, Potassium | 21 CFR 862.1600 | | Clinical Chemistry (75) | CGZ | Ion Specific Electrode, Chloride | 21 CFR 862.1170 | Proposed labeling · : Draft labeling sufficient to describe the device, its intended use, and the directions for use on the cobas c 501 analyzer module is included in the submission. . {2}------------------------------------------------ The ISE Gen 2 reagent was cleared in k053165 for application to the Roche/Hitachi family of analyzers. Device description The cobas 6000 analyzer series with an ISE module is an Ion-Selective Electrode (ISE) system for the determination of sodium, potassium, and chloride in serum, plasma, and urine. The cobas 6000 analyzer series, including the cobas c 501 with ISE for Serum, Plasma and Urine sample types was previously cleared in k060373. This premarket notification seeks to obtain FDA review and clearance for the cobas c 501 ISE, Modified Calibration for Serum, Plasma and Urine sample types. An ISE makes use of the unique properties of certain membrane materials to develop an electrical potential (electromotive force, EMF) for the measurements of ions in solution. The electrode has a selective membrane in contact with both the test solution and an internal filling solution. The internal filling solution contains the test ion at a fixed concentration. Because of the particular nature of the membrane; the test ions will closely associate with the membrane on each side. The membrane EMF is determined by the difference in concentration of the test ion in the test solution and the internal filling solution. The EMF develops according to the Nernst equation for a specific ion in solution (see package insert for further explanation). Aqueous ISE Standards Low and High were cleared in k053165. The modified calibration in this submission included the use of ISE Standards Low (S1) and High (S2) for 2-point calibration and the Standard High for compensation (S3). Previously, a serum-based ISE compensator was used for S3 compensation. The modification is switching from serum-based ISE compensator for S3 to ISE Standard High. In the new calibration scheme, the ISE Standard High will be used for both S2 and S3. #### Intended use The ISE module of the Roche/Hitachi cobas c systems is intended for the quantitative determination of sodium, potassium and chloride in serum. plasma or urine using ion-selective electrodes. {3}------------------------------------------------ ### Indications for use The ISE module of the Roche / Hitachi systems is intended for the quantitative determination of sodium, potassium, and chloride in serum, plasma, or urine using ion-selective electrodes. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Substantial equivalence comparison The following table compares the cobas c 501 ISE Gen. 2, Modified Calibration for Serum, Plasma and Urine sample types to its predicate device, the cobas c 501 analyzer module with ISE Gen.2 reagent, originally cleared in k053165. {4}------------------------------------------------ Comparison of Systems – similarities and differences : 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | | Parameter | Predicate: cobas.c 501 ISE Gen: 2 with serum-based ISE Compensator k053165 | cobas c 501 ISE Gen. 2, Modified Calibration, with ISE Standard High- (S3) | |--|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | | Intended use | The ISE module of the Roche/Hitachi cobas c system is intended for the quantitative determination of sodium, potassium and chloride in serum, plasma or urine using ion-selective electrodes. | Same | | | Measurement principle | ISE Potentiometry | Same | | | Reagent container | Plastic bottles closed via screw caps | Same | | | Onboard storage temperature | 5-12 °C | Same | | | ISE Module | Integrated into cobas c 501 analyzer | Same | | | Ion Selective electrodes (ISES) | Potentiometric chloride, potassium, sodium and reference electrodes | Same | . 11.11 : {5}------------------------------------------------ ### Comparison of assays – similarities and differences (Sodium) | Parameter | Predicate: cobas c 501-ISE Gen. 2 with serum-based ISE Compensator | | | cobas c 501 ISE Gen. 2, Modified Calibration, with ISE Standard High | | | | | |---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------|-------------|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-------------|--------| | Repeatability | | Mean [mmol/L] | SD [mmol/L] | CV [%] | | Mean [mmol/L] | SD [mmol/L] | CV [%] | | | Low | 124.8 | 0.36 | 0.3 | Low | 84.8 | 0.2 | 0.3 | | | High | 144.9 | 0.43 | 0.3 | Med | 121.4 | 0.3 | 0.3 | | | PNU | 124.9 | 0.38 | 0.3 | MDL | 131.6 | 0.3 | 0.2 | | | PPU | 149.2 | 0.35 | 0.3 | High | 176.7 | 0.3 | 0.2 | | | | | | | PNU | 126.0 | 0.2 | 0.2 | | | | | | | PPU | 148.2 | 0.3 | 0.2 | | Intermediate precision (CLSI) | | Mean [mmol/L] | SD [mmol/L] | CV [%] | | Mean [mmol/L] | SD [mmol/L] | CV [%] | | | Low | 124.9 | 0.75 | 0.6 | Low | 84.8 | 1.0 | 1.1 | | | High | 144.9 | 0.77 | 0.5 | Med | 121.4 | 0.8 | 0.6 | | | PNU | 124.7 | 0.75 | 0.6 | MDL | 131.6 | 0.7 | 0.5 | | | PPU | 149.9 | 0.80 | 0.5 | High | 176.7 | 0.6 | 0.4 | | | | | | | PNU | 126.0 | 0.7 | 0.6 | | | | | | | PPU | 148.2 | 0.5 | 0.4 | | Method Comparison to reference (Flame Photometer) | N = 51 (Plasma) Days = 3 Correlation = 0.993 Slope (Bablok) = 0.976 Intercept (Bablok) = +2.041 Range (X) = 132.7-164.1 | | | | N = 52 (Plasma) Days = 2 Correlation = 0.999 Slope (Bablok) = 1.000 Intercept (Bablok) = 0.200 Range (X) = 86.7-172 | | | | | | | | | | N = 51 (Serum) Days = 2 Correlation = 0.998 Slope (Bablok) = 0.992 Intercept (Bablok) = 1.633 Range (X) = 97.6-178 | | | | | Method comparison to predicate | N = 51 (Plasma) Days = 3 Correlation = 0.998 Slope (Bablok) = 1.000 Intercept (Bablok) = -0.100 Range (X) = 131.2-162.3 | | | | N = 52 (Plasma) Days = 2 Correlation = 1.000 Slope (Bablok) = 1.016 Intercept (Bablok) = -1.456 Range (X) = 87.6-170 | | | | | | | | | | N = 51 (Serum) Days = 2 Correlation = 0.999 Slope (Bablok) = 1.009 Intercept (Bablok) = -0.515 Range (X) = 97.3-176 LoB = 3.9 mmol/L | | | | | Detection Limit | Not determined | | | | LoD = 5.7 mmol/L LoQ = 11.1 mmol/L | | | | | Reportable range | 80-180 mmol/L | | | | 80-180 mmol/L | | | | : · {6}------------------------------------------------ # Comparison of assays – similarities and differences (Sodium) | | Assay Comparison Sodium - Urine | | | | | | | | |---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------|----------------|-----------|------------------------------------------------------------------------------------------------------------------------------|------------------|----------------|-----------| | Parameter | Predicate: cobas c 501 ISE Gen. 2 with serum-based ISE Compensator | | | | cobas c 501 ISE Gen. 2, Modified Calibration, with ISE Standard High | | | | | | | Mean [mmol/L] | SD [mmol/L] | CV [%] | | Mean [mmol/L] | SD [mmol/L] | CV [%] | | Repeatability | Low | 16.7 | 0.27 | 1.6 | Low | 30.6 | 0.1 | 0.2 | | | High | 166.8 | 0.63 | 0.4 | Med | 131.7 | 0.2 | 0.2 | | | Liq 1 | 76.3 | 0.31 | 0.4 | MDL | 23.3 | 0.1 | 0.3 | | | Liq 2 | 175.5 | 0.47 | 0.3 | High | 236.7 | 0.4 | 0.2 | | | | | | | Liq 1 | 81.6 | 0.2 | 0.2 | | | | | | | Liq 2 | 172.3 | 0.2 | 0.1 | | | | Mean [mmol/L] | SD [mmol/L] | CV [%] | | Mean [mmol/L] | SD [mmol/L] | CV [%] | | Intermediate precision (CLSI) | Low | 15.5 | 0.62 | 4.0 | Low | 30.6 | 0.9 | 3.0 | | | High | 166.7 | 0.87 | 0.5 | Med | 131.7 | 0.6 | 0.5 | | | Liq 1 | 75.7 | 0.75 | 1.0 | MDL | 23.3 | 0.9 | 3.8 | | | Liq 2 | 176.6 | 1.07 | 0.6 | High | 236.7 | 1.3 | 0.6 | | | | | | | Liq 1 | 81.6 | 1.3 | 1.6 | | | | | | | Liq 2 | 172.3 | 2.6 | 1.5 | | Method Comparison to reference (flame photometer) | N = 51 Days = 3 Correlation = 1.000 Slope (Bablok) = 1.001 Intercept (Bablok) = -1.263 Range (X) = 19.9-257.4 | | | | N = 100 Days = 2 Correlation = 1.000 Slope (Bablok) = 0.964 Intercept (Bablok) = 4.032 Range (X) = 23.5-249.8 | | | | | Method comparison to predicate | N = 51 Days = 3 Correlation = 1.000 Slope (Bablok) = 1.011 Intercept (Bablok) = -0.247 Range (X) = 17.9 -253.0 | | | | N = 100 Days = 2 Correlation = 1.000 Slope (Bablok) = 0.995 Intercept (Bablok) = 0.687 Range (X) = 25.1-245.4 | | | | | Detection Limit | Not determined | | | | LoB = 3.9 mmol/L LoD = 5.7 mmol/L LoQ = 11.1 mmol/L | | | | | Reportable range | 10-250 mmol/L | | | | 20 - 250 mmol/L | | | | | Extended Range | 250-375 mmol/L (samples diluted via rerun function) | | | | 250 - 375 mmol/L (samples diluted via rerun function) | | | | {7}------------------------------------------------ ## Comparison of assays – similarities and differences, (Potassium) . · . | Parameter | Predicate: cobas c 501 ISE Gen. 2, with serum-based ISE Compensator | | | cobas c 501 ISE Gen. 2, Modified Calibration, with ISE Standard High | | | |---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------| | | Mean [mmol/L] | SD [mmol/L] | CV [%] | Mean [mmol/L] | SD [mmol/L] | CV [%] | | Repeatability | Low 4.68 | 0.03 | 0.5 | Low 1.62 | 0.01 | 0.7 | | | High 8.62 | 0.04 | 0.5 | Med 4.97 | 0.04 | 0.7 | | | PNU 3.37 | 0.02 | 0.5 | MDL 2.63 | 0.02 | 0.6 | | | PPU 6.06 | 0.03 | 0.5 | High 9.46 | 0.06 | 0.6 | | | | | | PNU 3.57 | 0.03 | 0.8 | | | | | | PPU 6.59 | 0.04 | 0.6 | | Intermediate precision (CLSI) | Mean [mmol/L] | SD [mmol/L] | CV [%] | Mean [mmol/L] | SD [mmol/L] | CV [%] | | | Low 4.72 | 0.03 | 0.7 | Low 1.62 | 0.03 | 1.6 | | | High 8.63 | 0.04 | 0.5 | Med 4.97 | 0.04 | 0.8 | | | PNU 3.39 | 0.02 | 0.5 | MDL 2.63 | 0.03 | 1.0 | | | PPU 6.08 | 0.03 | 0.6 | High 9.46 | 0.07 | 0.7 | | | | | | PNU 3.57 | 0.04 | 1.0 | | | | | | PPU 6.59 | 0.05 | 0.7 | | Method Comparison to reference (Flame Photometry) | N = 51 (Plasma) Days = 3 Correlation = 0.998 Slope (Bablok) = 0.983 Intercept (Bablok) = -0.026 Range (X) = 3.23-6.35 | | | N = 52 (Plasma) Days = 2 Correlation = 1.000 Slope (Bablok) = 1.010 Intercept (Bablok) = - 0.022 Range (X) = 2.1-9.19 N = 54 (Serum) Days = 2 Correlation = 1.000 Slope (Bablok) = 1.005 Intercept (Bablok) = -0.020 Range (X) = 1.59-9.56 | | | | Method comparison to predicate | N = 51 (Plasma) Days = 3 Correlation = 0.998 Slope (Bablok) = 0.988 Intercept (Bablok) = 0.052 Range (X) = 3.14-6.26 | | | N = 52 (Plasma) Days = 2 Correlation = 1.000 Slope (Bablok) = 1.008 Intercept (Bablok) = 0.018 Range (X) = 2.02-9.13 N = 54 (Serum) Days = 2 Correlation = 1.000 Slope (Bablok) = 1.004 Intercept (Bablok) = 0.302 Range (X) = 1.52-9.45. | | | | Detection Limit | Not determined | | | LoB = 0.17 mmol/L LoD = 0.24 mmol/L LoQ = 0.41 mmol/L | | | | Reportable range | 1.5-10.0 mmol/L | | | 1.5 - 10.0 mmol/L | | | {8}------------------------------------------------ ### Comparison of assays – similarities and differences, (Potassium) | Assay Comparison | | | | | | | | | |---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------|-----------|--| | Potassium - Urine | | | | | | | | | | Parameter | Predicate: cobas c 501 ISE Gen. 2 with serum-based ISE Compensator | | | | cobas c 501 ISE Gen. 2, Modified Calibration, with ISE Standard High | | | | | | Mean [mmol/L] | SD [mmol/L] | CV [%] | | Mean [mmol/L] | SD [mmol/L] | CV [%] | | | Repeatability | Low 8.79 | 0.04 | 0.4 | Low 5.15 | 0.03 | 0.6 | | | | | High 72.04 | 0.53 | 0.7 | Med 52.08 | 0.32 | 0.6 | | | | | Liq 1 31.13 | 0.21 | 0.7 | MDL 15.39 | 0.09 | 0.6 | | | | | Liq 2 68.76 | 0.36 | 0.5 | High 90.34 | 0.67 | 0.7 | | | | | | | | Liq 1 31.48 | 0.19 | 0.6 | | | | | | | | Liq 2 70.56 | 0.43 | 0.6 | | | | Intermediate precision (CLSI) | Mean [mmol/L] 8.99 | SD [mmol/L] 0.04 | CV [%] 0.4 | Mean [mmol/L] 5.15 | SD [mmol/L] 0.04 | CV [%] 0.7 | | | | | High 72.04 | 0.53 | 0.7 | Med 52.08 | 0.67 | 1.3 | | | | | Liq 1 31.13 | 0.21 | 0.7 | MDL 15.39 | 0.14 | 0.9 | | | | | Liq 2 68.76 | 0.36 | 0.5 | High 90.34 | 1.38 | 1.5 | | | | | | | | Liq 1 31.48 | 0.53 | 1.7 | | | | | | | | Liq 2 70.56 | 1.17 | 1.7 | | | | Method Comparison to reference (Flame Photometry) | N = 51 Days = 3 Correlation = 1.000 Slope (Bablok) = 1.033 Intercept (Bablok) = -0.023 Range (X) = 9.20-95.10 | | | N = 105 Days = 2 Correlation = 1.000 Slope (Bablok) = 1.018 Intercept (Bablok) = 0.397 Range (X) = 4.00-97.20 | | | | | | Method comparison to predicate | N = 51 Days = 3 Correlation = 0.999 Slope (Bablok) = 0.982 Intercept (Bablok) = 0.323 Range (X) = 9.68-98.55 | | | N = 105 Days = 2 Correlation = 0.999 Slope (Bablok) = 0.997 Intercept (Bablok) = 0.062 Range (X) = 4.05-97.35 | | | | | | Detection Limit | Not determined | | | LoB = 0.17 mmol/L LoD = 0.24 mmol/L LoQ = 0.41 mmol/L | | | | | | Reportable range | 1 -100 mmol/L | | | 3 - 100 mmol/L | | | | | | Extended Range | 100-150 mmol/L (samples diluted via rerun function) | | | 100 -150 mmol/L (samples diluted via rerun function) | | | | | : {9}------------------------------------------------ ### Comparison of assays – similarities and differences, (Chloride) . . | Assay Comparison | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--| | Chloride | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Parameter | Predicate: cobas c 501 ISE Gen. 2 with serum-based ISE Compensator | cobas c 501 ISE Gen. 2, Modified Calibration, with ISE Standard High | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Repeatability | Mean [mmol/L] SD [mmol/L] CV [%] Low 86.6 0.30 0.3 High 118.4 0.38 0.3 PNU 82.1 0.41 0.5 PPU 114.7 0.31 0.3 | | | | | | | | | | | | | | | | | | | | | Mean [mmol/L] SD [mmol/L] CV [%] Low 68.5 0.2 0.3 Med 129.0 0.4 0.3 MDL 92.3 0.2 0.3 High 139.0 0.3 0.2 PNU 86.2 0.2 0.3 PPU 119.2 0.3 0.2 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Intermediate precision (CLSI) | Mean [mmol/L] SD [mmol/L] CV [%] Low 88.2 0.55 0.6 High 118.4 0.61 0.5 PNU 81.9 0.36 0.4 PPU 115.4 0.62 0.5 | | | | | | | | | | | | | | | | | | | | | Mean [mmol/L] SD [mmol/L] CV [%] Low 68.5 0.6 0.8 Med 129.0 0.6 0.5 MDL 92.3 0.5 0.6 High 139.0 0.6 0.4 PNU 86.2 0.5 0.6 PPU 119.2 0.5 0.4 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Method Comparison to reference (Coulometry) | N = 51 (Plasma) Days = 3 Correlation = 0.995 Slope (Bablok) = 0.954 Intercept (Bablok) = +1.438 Range (X) = 92.0 - 132.0 | N = 52 (Plasma) Days = 2 Correlation = 0.998 Slope (Bablok) = 1.023 Intercept (Bablok) = -0.769 Range (X) = 69.0 - 133 N = 53 (Serum) Days = 2 Correlation = 0.999 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Method comparison to predicate | N = 51 (Plasma) Days = 3 Correlation = 0.999 Slope (Bablok) = 0.978 Intercept (Bablok) = +1.744 Range (X) = 90.7-128.9 | Slope (Bablok) = 1.043 Intercept (Bablok) = -2.843 Range (X) = 62.0 - 136 N = 52 (Plasma) Days = 2 Correlation = 0.999 Slope (Bablok) = 1.006 Intercept (Bablok) = -0.118 Range (X) = 69.4-134 N = 53 (Serum) Days = 2 Correlation = 1.000 Slope (Bablok) = 0.997 Intercept (Bablok) = 0.872 Range (X) = 61.4 - 138 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Detection Limit | Not determined | LoB = 3.40 mmol/L LoD = 4.7 mmol/L LoQ = 5.5 mmol/L | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Reportable range | 60-140 mmol/L | 60-140 mmol/L | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | {10}------------------------------------------------ Comparison of assays similarities and differences, (Chloride) | Assay Comparison | | | | | | | | | | | | | | |----------------------|--------------------------------------------------------|---------------------------------------------------|----------|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------|-----|--|--|--|--|--| | Chloride - Urine | | | | | | | | | | | | | | | arameter | | Predicate: cobas c 501 ISE cobas c 501 ISE Gen. 2 | | | 视频中国网站 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Gen. 2 with serum-based - - - Modified Calibration, | | | | | | | | | | | | | | | ISE.Compensator -------------------------------------------------------------------------------------------------------------------------------------------------------------- | | | | | | | | | | | | Mean | SD | CV | | Mean | SD | CV | | | | | | | Repeatability | | [mmol/L] | [mmol/L] | [%] | | [mmol/L] | [mmol/L] | [%] | | | | | | | | Low | 20.4 | 0.29 | 1.4 | Low | 25.8 | 0.1 | 0.2 | | | | | | | | High | 165.0 | 0.81 | 0.5 | Med | 131.4 | 0.3 | 0.2 | | | | | | | | Lig 1 | 101.9 | 0.43 | 0.4 | MDL | 24.3 | 0.1 | 0.3 | | | | | | | | Liq 2 | 203.0 | 0.54 | 0.3 | High | 243.4 | 0.6 | 0.2 | | | | | | | | | | | | Liq 1 | 97.5 | 0.2 | 0.2 | | | | | | | | | | | | Lig 2 | 198.2 | 0.4 | 0.2 | | | | | | | | | Mean | SD | CV | | Mean | SD | CV | | | | | | | Intermediate | | [mmol/L] | [mmol/L] | 1%] | | [mmol/L] | [mmol/L] | [%] | | | | | | | precision | Low | 1 0 0 | 0.55 | 2.8 | Low | -25.8 | 0.6 | 2.3 | | | | | | | (CLSI) | High | 165.4 | 1.17 | 0.7 | Med | 131.4 | 0.7 | 0.5 | | | | | | | | Liq 1 | 101.5 | 0.34 | 0.3 | MDL | 24.3 | 0.6 | 2.4 | | | | | | | | Liq 2 | 206.1 | 1.26 | 0.6 | High | 243.4 | 1.8 | 0.7 | | | | | | | | | | | | Lig 1 | 97.5 | 1 Q | 1.6 | | | | | | | | | | | | Lig 2 | 198.2 | 2.3 | 1.2 | | | | | | | Method | N = 51 | | | | N = 105 | | | | | | | | | | Comparison | Days = 3 | | | | Days = 2 | | | | | | | | | | to reference | | Correlation = 1.000 | | | | Correlation = 0.998 | | | | | | | | | (Coulometry) | Slope (Bablok) = 1.002 Intercept (Bablok) = - 2.739 | | | | Slope (Bablok) = 1.020 | | | | | | | | | | | | Range (X) = 21.0-274.0 | | | Intercept (Bablok) = - 1.700 Range (X) = 22.0 - 248.0 | | | | | | | | | | | | | | | N = 105 | | | | | | | | | | Method comparison | N = 51 | | | | Days = 2 | | | | | | | | | | to predicate | | Days = 3 Correlation = 1.000 | | | | Correlation = 1.000 | | | | | | | | | | | Slope (Bablok) = 1.009 | | | | Slope (Bablok) = 0.989 | | | | | | | | | | | Intercept (Bablok) = - 1.715 | | | | Intercept (Bablok) = 0.669 | | | | | | | | | | | Range (X) = 18.5-269.0 | | | | Range (X) = 21.2-249.9 | | | | | | | | | Detection | | | | | | LoB = 3.4 mmol/L | | | | | | | | | Limit | Not determined | | | | LoD = 4.7 mmol/L | | | | | | | | | | | | | | | LoQ=5.5 mmol/L | | | | | | | | | | Reportable | 10 -250 mmol/L | | | | 20 - 250 mmol/L | | | | | | | | | | range | | | | | | | | | | | | | | | Extended | 250 - 375 mmol/L | | | | 250 - 375 mmol/L | | | | | | | | | | Range | (samples diluted via rerun . function) | | | | (samples diluted via rerun function) | | | | | | | | | | | | | | | | | | | | | | | | ### Conclusion: The data presented in this premarket notification demonstrates cobas c 501 ISE Gen. 2 assay with the modified calibration performs substantially equivalent to the predicate device, the cobas c 501 ISE Gen. 2 with the original calibration (k053165). {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 18, 2013 ROCHE DIAGNOSTICS KHOA TRAN REGULATORY AFFAIRS CONSULTANT 9115 HAGUE ROAD INDIANAPOLIS IN 46250 Re: K132418 Trade/Device Name: cobas c 501 ISE Indirect Na, K, Cl for Gen. 2 Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: II Product Code: JGS, CEM, CGZ Dated: December 12, 2013 Received: December 13, 2013 Dear Mr. Tran: 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 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 Parts 801 and 809); medical device reporting (reporting of medical device-related 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. {12}------------------------------------------------ Page 2-Mr. Tran If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21.CFR Part 807.97). For questions regarding 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/Industrv/default.htm. Sincerely yours. Carol Benson -S for Courtney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {13}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. 510(k) Number (if known) k132418 Device Name cobas c 501 ISE Indirect Na, K, Cl for Gen. 2 Indications for Use (Describe) The ISE module of the Roche / Hitachi systems is intended for the quantitative determination of sodium. potassium. and chloride in serum, plasma, or urine using ion-selective electrodes. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration…