(34 days)
The ISE module of the COBAS INTEGRA systems is intended for use for the quantitative determination of sodium, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma, using ion-selective electrodes. This Chloride electrode is recommended to be used if a significant amount of the samples are plasma samples. Serum and urine samples may also be analyzed with this electrode. Chloride measurements are used in diagnosis and treatment of electrolyte and metabolic disorders.
The ISE module of the COBAS INTEGRA systems is intended for use for the quantitative determination of sodium, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma, using ion-selective electrodes. The ion-selective electrode is using undiluted (ISE Direct) or automatically diluted (ISE Indirect, ISE Urine) specimens. This Chloride electrode is recommended to be used if a significant amount of the samples are plasma samples. Serum and urine samples may also be analyzed with this electrode.
Here's a breakdown of the acceptance criteria and study information for the Chloride Electrode Gen. 2, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the "Modified Chloride Electrode Gen. 2" to a "Predicate Device – Chloride Electrode (approved via K963627)". While explicit "acceptance criteria" for the modified device are not stated as separate numerical targets, the study's goal is to demonstrate "substantial equivalence" to the predicate. Therefore, the "acceptance criteria" implicitly are that the modified device's performance should be comparable to or better than the predicate device for all relevant characteristics, and within acceptable clinical ranges.
The table below summarizes the key performance characteristics that were compared:
| Feature | Predicate Device Performance (K963627) | Modified Chloride Electrode Gen. 2 Performance |
|---|---|---|
| Stability (Onboard) | 2 months or 6000 samples (reduced when majority of plasma samples are used) | 3 months (serum samples only, reduced when plasma samples are used) |
| Precision (ISE Direct mode, Serum) | Within run CV% (n=20): 0.19% @ 92.9 mmol/L, 0.19% @ 127.2 mmol/L Between run CV% (n=20): 0.9% @ 94.3 mmol/L, 1.1% @ 126.5 mmol/L | Within run CV% (n=21): 0.69% @ 86 mmol/L, 0.46% @ 99 mmol/L Between day CV% (n=21): 1.3% @ 86 mmol/L, 0.92% @ 99 mmol/L Total CV% (n/a): 0.9% @ 94.4 mmol/L, 1.1% @ 126.4 mmol/L |
| Precision (ISE Direct mode, Plasma) | Within run CV% (n/a): N/A Between run CV% (n/a): N/A | Within run CV% (low n=20, high n=21): 0.36% @ 89.2 mmol/L, 0.15% @ 125 mmol/L Between day CV% (n=21): 1.0% @ 91.6 mmol/L, 1.2% @ 126.0 mmol/L Total CV% (n/a): 1.0% @ 91.8 mmol/L, 1.4% @ 125.8 mmol/L |
| Precision (ISE Indirect mode, Serum) | Within run CV% (n/a): N/A Between run CV% (n/a): N/A | Within run CV% (n=21): 0.65% @ 90.3 mmol/L, 0.25% @ 124.1 mmol/L Between day CV% (n=21): 1.0% @ 92.0 mmol/L, 0.9% @ 122.8 mmol/L Total CV%: 1.0%@ 92.1mmol/L, 1.0% @ 122.8 mmol/L |
| Precision (ISE Indirect mode, Plasma) | Within run CV% (n/a): N/A Between run CV% (n/a): N/A | Within run CV% (n=21): 0.29% @ 86.4 mmol/L, 0.23% @ 121.9 mmol/L Between day CV% (n=21): 1.1% @ 88.7 mmol/L, 1.0% @ 121.6 mmol/L Total CV%: 1.1% @ 88.8 mmol/L, 1.0% @ 121.6 mmol/L |
| Precision (ISE Indirect mode) | Within run CV% (n=20): 0.77% @ 87 mmol/L, 0.72% @ 101 mmol/L Between run CV% (n=20): 1.5% @ 87 mmol/L, 1.2% @ 101 mmol/L | (Specific to serum/plasma concentrations as above) |
| Precision (ISE Urine mode) | Within run CV% (n=20): 0.97% @ 53 mmol/L, 1.2% @ 267 mmol/L Between run CV% (n=20): 2.8% @ 53 mmol/L, 2.2% @ 267 mmol/L | Within run CV% (low n=21, high n=20): 0.5% @ 61.4 mmol/L, 0.5% @ 194.4 mmol/L Between day (n=21): 2.3% @ 64.9 mmol/L, 4.3% @ 186.4 mmol/L Total: 2.8% @ 65.1mmol/L, 4.4% @ 186.5 mmol/L |
| Linearity (Serum/Plasma) | ISE Direct: 20-250 mmol/L; ISE Indirect: 20-250 mmol/L | ISE Direct: 60-140 mmol/L; ISE Indirect: 60-140 mmol/L |
| Linearity (Urine) | 20-350 mmol/L | 20-250 mmol/L |
| Sensitivity for electrode: slope | -42 to -56 mV/dec | ISE Direct: -35 to -56 mV/dec; ISE Indirect: -38 to -56 mV/dec |
2. Sample Sizes and Data Provenance for the Test Set
- Sample Size for Precision Studies:
- ISE Direct mode (Modified Device):
- Within run CV%: n=21 for serum (86 mmol/L and 99 mmol/L), n=20 (low) and n=21 (high) for plasma (89.2 mmol/L and 125 mmol/L).
- Between day CV%: n=21 for serum (86 mmol/L and 99 mmol/L), n=21 for plasma (91.6 mmol/L and 126.0 mmol/L).
- ISE Indirect mode (Modified Device):
- Within run CV%: n=21 for serum (90.3 mmol/L and 124.1 mmol/L), n=21 for plasma (86.4 mmol/L and 121.9 mmol/L).
- Between day CV%: n=21 for serum (92.0 mmol/L and 122.8 mmol/L), n=21 for plasma (88.7 mmol/L and 121.6 mmol/L).
- ISE Urine mode (Modified Device):
- Within run CV%: n=21 (low) and n=20 (high) for urine (61.4 mmol/L and 194.4 mmol/L).
- Between day CV%: n=21 for urine (64.9 mmol/L and 186.4 mmol/L).
- (Predicate Device Precision): Sample sizes for the predicate device's precision studies (n=20 for within-run and between-run CV%) are also mentioned for comparison.
- ISE Direct mode (Modified Device):
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is a laboratory performance study rather than a clinical study with patient samples for diagnosis. The samples would typically be control materials or spiked samples.
3. Number of Experts and Qualifications for Ground Truth
- N/A. This device is an in vitro diagnostic (IVD) for quantitative determination of analytes using an ion-selective electrode. The "ground truth" for performance studies like precision and linearity is established through reference methods, certified reference materials, or gravimetric preparations, not expert clinical consensus.
4. Adjudication Method
- N/A. As this is an IVD device performance study, there is no expert adjudication of results. The performance is assessed against established analytical standards and the predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not a diagnostic imaging device or an AI-assisted diagnostic tool that involves human readers. It's an automated laboratory assay.
6. Standalone Performance (Algorithm Only)
- Yes, effectively. The performance data presented (precision, linearity, sensitivity, interference) are all measures of the device's inherent analytical performance without human intervention in the measurement process (beyond operating the instrument). This is a standalone performance study of the device itself.
7. Type of Ground Truth Used
- The ground truth for these types of studies is based on:
- Reference materials/known concentrations: For precision, linearity, and sensitivity, samples with known or target concentrations of chloride are used.
- Comparative methods: The performance is also implicitly compared to the predicate device, which itself would have been validated against established reference methods.
- Clinical ranges: Expected values for adults are given, implying the device measures within clinically relevant ranges.
8. Sample Size for the Training Set
- N/A. This is not a machine learning or AI device that requires a "training set." It's an ion-selective electrode system.
9. How Ground Truth for the Training Set Was Established
- N/A. See point 8.
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K 060/08
FEB 1 6 2006
510(k) Summary - Chloride Electrode Gen. 2
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|---|---|
| Submitter name, address, contact | Roche Diagnostics Corporation9115 Hague RdIndianapolis IN 46250(317) 521-3831 |
| Contact person: Corina Harper | |
| Date prepared: January 12, 2006 | |
| Chloride Electrode Gen. 2 | Proprietary name: COBAS INTEGRA Chloride Electrode Gen. 2 |
| Common name: Chloride Test System | |
| Classification name: Ion-Specific Electrode Chloride | |
| Device description | The ISE module of the COBAS INTEGRA systems is intended for use for the quantitative determination of sodium, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma, using ion-selective electrodes. |
| The ion-selective electrode is using undiluted (ISE Direct) or automatically diluted (ISE Indirect, ISE Urine) specimens. | |
| This Chloride electrode is recommended to be used if a significant amount of the samples are plasma samples. Serum and urine samples may also be analyzed with this electrode. | |
| Continued on next page |
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| Intended use |
|---|
| The ISE module of the COBAS INTEGRA systems is intended for use for thequantitative determination of sodium, potassium, chloride in serum, plasmaand urine, and lithium in serum and plasma, using ion-selective electrodes.This Chloride electrode is recommended to be used if a significant amount ofthe samples are plasma samples. Serum and urine samples may also beanalyzed with this electrode. |
| PredicateDevice |
| We claim substantial equivalence to the currently marketed ISE ChlorideElectrode cleared for use under K963627 on October 24, 1996. |
| Substantialequivalency -similarities |
| The table below indicates the similarities between the predicate device(K963627) and the modified Chloride Electrode Gen. 2. |
| Feature | Predicate Device – ChlorideElectrode(approved via K963627) | Modified Chloride Electrode Gen. 2 |
|---|---|---|
| General | ||
| Intended Use | ISE Direct:The ISE module of the COBAS INTEGRAsystems is intended for use for the quantitativedetermination of sodium, potassium, chlorideand lithium concentrations in undiluted serumand plasma using ion-selective electrode.ISE Indirect:The ISE module of the COBAS INTEGRAsystems is intended for use for the quantitativedetermination of sodium, potassium, chlorideconcentrations in diluted serum and plasmausing ion-selective electrode.ISE in Urine:The ISE module of the COBAS INTEGRAsystems is intended for use for the quantitativedetermination of sodium, potassium, chlorideconcentrations in diluted urine using ion-selective electrode. | The ISE module of the COBAS INTEGRAsystems is intended for use for the quantitativedetermination of sodium, potassium, chloridein serum, plasma and urine, and lithium inserum and plasma, using ion-selectiveelectrodes.This Chloride electrode is recommended to beused if a significant amount of the samples areplasma samples. Serum and urine samples mayalso be analyzed with this electrode. |
| Sample type | Serum, plasma, urine | Same |
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| Feature | Predicate Device -- ChlorideElectrode(approved via K963627) | Modified Chloride Electrode Gen. 2 |
|---|---|---|
| Electrode Information | ||
| Calibrator | ISE solutions 1,2,3ISE Calibrator DirectISE Calibrator Indirect/Urine5 hours calibration interval (maincalibration), every sample (one-pointcalibration) | Same |
| Qualitycontrol | Serum/Plasma: PreciNorm U,Precipath UUrine: Quantitative Urine Controls | Same |
| Performance Characteristics | ||
| Expectedvalues foradults -mmol/L | ISE Direct Serum/Plasma 101-110ISE Indirect Serum/plasma 98-107ISE Urine 110-250 | Same |
Substantial equivalency - similarities (continued)
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| Feature | Predicate Device – ChlorideElectrode(approved via K963627) | Modified Chloride Electrode Gen. 2 |
|---|---|---|
| EndogenousInterferences | ISE Direct and Indirect(serum/plasma):Hemolysis – no significantinterferences up to a hemoglobin levelof 10 g/LLipemia - no significant interferencesIcterus – no significant interferences | Same |
| ExogenousInterference | ISE Direct (serum/plasma)Probenecid causes artificially highchloride concentrations. | ISE Direct (serum/plasma)Ca-Dobesilate, Phenylbutazone,Acetylsalicylic acid and Ibuprofencauses artificially high chlorideconcentrations. |
| Salicylic acid concentration of 1.2mmol/L increase chlorideconcentration by aprox. 10% | Same | |
| ISE Indirect (serum/plasma)Acetylsalicylic acid causes artificialhigh Chloride concentrations. | ISE Indirect(serum/plasma)Acetylsalicylic acid and Ibuprofencauses artificial high chlorideconcentrations. | |
| ISE UrineDrug panel tested caused nosignificant interferences up to theindicated concentrations in the label. | ISE Urine:Ascorbic acid, Ca-Dobesilate andLevodopa causes artificially highchloride concentrations. | |
Substantial equivalency - similarities (continued)
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Substantial equivalency differences
The table below indicates the differences between the predicate device (K963627) and the modified Chloride Electrode Gen. 2.
Modified Chloride Electrode Gen. 2 Predicate Device - Chloride Feature Electrode (approved via K963627) 2 months or 6000 samples Onboard 3 months (serum samples only, reduced when (when majority of plasma samples are Stability used) plasma sample are used) Performance Characteristics Within run CV% (n=21): Within run CV% (n=20): Precision 0.69% @ 86 mmol/L Serum: ISE Direct 0.19% @ 92.9 mmol/L mode 0.46% (@, 99mmol/L 0.19% @ 127.2 mmol/L CV% Plasma (low n=20, high n=21): 0.36% @ 89.2 mmol/L 0.15% @ 125 mmol/L Between day CV% (n=21): Between run CV% (n=20): Serum: 1.3% @ 86 mmol/L 0.9% @ 94.3 mmol/L 0.92%@ 99 mmol/L 1.1% (@, 126.5 mmol/L Plasma: 1.0% (@, 91.6 mmol/L 1.2% @, 126.0 mmol/L Total CV% Serum: 0.9%@ 94.4 mmol/L 1.1% (@, 126.4 mmol/L Plasma: 1.0% @ 91.8 mmol/L 1.4% @ 125.8 mmol/L
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| Feature | Predicate Device - ChlorideElectrode(approved via K963627) | Modified Chloride Electrode Gen. 2 |
|---|---|---|
| Performance Characteristics | ||
| ISE IndirectmodeCV% | Within run CV% (n=20):0.77% @ 87 mmol/L0.72% @ 101 mmol/L | Within run CV%(n=21):Serum:0.65% @ 90.3 mmol/L0.25% @ 124.1 mmol/LPlasma:0.29% @ 86.4 mmol/L0.23% @ 121.9 mmol/L |
| Between run CV% (n=20):1.5% @ 87 mmol/L1.2% @ 101 mmol/L | Between day CV%(n=21):Serum:1.0% @ 92.0 mmol/L0.9% @ 122.8 mmol/LPlasma:1.1% @ 88.7 mmol/L1.0% @ 121.6 mmol/L | |
| Total CV%:Serum:1.0%@ 92.1mmol/L1.0% @ 122.8 mmol/LPlasma:1.1% @ 88.8 mmol/L1.0% @ 121.6 mmol/L |
Substantial equivalency - differences (continued)
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ース | アイトレストー | アイト | アイト | アイト | アイト | アイト | アイト | アイト | アート | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Feature | Predicate Device - ChlorideElectrode | Modified Chloride Electrode Gen. 2 |
|---|---|---|
| (approved via K963627) | ||
| ISE UrinemodeCV% | Within run CV% (n=20):0.97% @ 53 mmol/L1.2% @ 267 mmol/L | Within run CV% (low n=21, high n=20):0.5% @ 61.4 mmol/L0.5% @ 194.4 mmol/L |
| Between run CV% (n=20):2.8% @ 53 mmol/L2.2% @ 267 mmol/L | Between day (n=21):2.3% @ 64.9 mmol/L4.3% @ 186.4 mmol/L | |
| Total:2.8% @ 65.1mmol/L4.4% @ 186.5 mmol/L | ||
| Linearity(mmol/L) | ISE Direct - Serum/plasma: 20-250ISE Indirect - Serum/plasma: 20-250ISE Urine: 20-350 | ISE Direct -- Serum/Plasma: 60-140ISE Indirect - Serum/Plasma: 60-140ISE Urine: 20-250 |
| Sensitivity forelectrode:slope | -42 to -56 mV/dec | ISE Direct: -35 to -56 mV/decISE Indirect: -38 to -56 mV/dec |
Substantial equivalency - differences (continued)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/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 three curved lines representing its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 6 2006
Ms. Corina Harper Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256
K060108 Re: Trade/Device Name: Chloride Electrode Gen. 2 Regulation Number: 21 CFR§ 862.1170 Regulation Name: Chloride test system Regulatory Class: Class II Product Code: CGZ Dated: January 12, 2006 Received: January 27, 2006
Dear Ms. Harper
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I mb lotter will and myour your e FDA finding of substantial equivalence of your device to a legally promated nearly and the results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or guestions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Guti
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Chloride Electrode Gen. 2: Chloride Electrode Gen. 2
Indications For Use:
The ISE module of the COBAS INTEGRA systems is intended for use for the The 15L module of the 00DTro iive, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma, using ion-selective electrodes.
This Chloride electrode is recommended to be used if a significant amount of the samples I mis Chornia samples. Serum and urine samples may also be analyzed with this electrode.
Chloride measurements are used in diagnosis and treatment of electrolyte and metabolic disorders.
Prescription Use XXX
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benem
Sign-On
ിfice of In Vitro Diagnostic Device ivaluation and Safety
§ 862.1170 Chloride test system.
(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.