Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on ion-selective electrode technology for quantitative determination of electrolytes, with no mention of AI or ML terms, image processing, or data sets typically associated with AI/ML model training or testing.

Therapeutic

No.

The device is for in vitro diagnostic (IVD) use, specifically for the quantitative determination of electrolytes in biological samples. It aids in diagnosis and treatment but does not directly provide therapy.

Diagnostic

Yes

The "Intended Use" section explicitly states that "Chloride measurements are used in diagnosis and treatment of electrolyte and metabolic disorders," indicating its direct involvement in disease diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it uses "ion-selective electrodes," which are hardware components. The summary also discusses performance characteristics related to the electrode itself (e.g., sensitivity for electrode slope), further indicating it is not software-only.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states the device is for the "quantitative determination of sodium, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma". These are all biological samples taken in vitro (outside the body).
Diagnostic Purpose: The intended use also states that "Chloride measurements are used in diagnosis and treatment of electrolyte and metabolic disorders." This clearly indicates a diagnostic purpose.
Device Description: The description reinforces the use of "undiluted (ISE Direct) or automatically diluted (ISE Indirect, ISE Urine) specimens," which are biological samples.
Method: The device uses "ion-selective electrodes," which is a common method for analyzing chemical components in biological fluids in vitro.

The information provided strongly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

CGZ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The document provides comparative performance characteristics between the predicate device and the modified Chloride Electrode Gen. 2 across several features:

Onboard Stability: Modified device has 2 months or 6000 samples, compared to 3 months (serum only, reduced when plasma samples are used) for the predicate.
Precision: Within run CV% and Between day CV% (or Between run CV% for predicate) are provided for ISE Direct mode (serum/plasma), ISE Indirect mode (serum/plasma), and ISE Urine mode. Sample sizes (n) of 20 or 21 are indicated for the CV% calculations for both predicate and modified device.
Linearity (mmol/L):
- ISE Direct - Serum/plasma: Predicate (20-250), Modified (60-140)
- ISE Indirect - Serum/plasma: Predicate (20-250), Modified (60-140)
- ISE Urine: Predicate (20-350), Modified (20-250)
Sensitivity for electrode: slope (mV/dec): Predicate (-42 to -56), Modified (ISE Direct: -35 to -56, ISE Indirect: -38 to -56).

Key results include detailed CV% values at different concentration levels, indicating the precision of the device. The linearity ranges define the operational concentration limits, and the sensitivity slope indicates the electrode's responsiveness.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Precision: Within run CV%, Between day CV% (or Between run CV%)
Linearity
Sensitivity for electrode: slope

Predicate Device(s)

K963627

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

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 Corporation
9115 Hague Rd
Indianapolis 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

1

Intended use
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. |
| Predicate
Device |
| We claim substantial equivalence to the currently marketed ISE Chloride
Electrode cleared for use under K963627 on October 24, 1996. |
| Substantial
equivalency -
similarities |
| The table below indicates the similarities between the predicate device
(K963627) and the modified Chloride Electrode Gen. 2. |

| Feature | Predicate Device – Chloride
Electrode
(approved via K963627) | Modified Chloride Electrode Gen. 2 |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | |
| Intended Use | ISE Direct:
The ISE module of the COBAS INTEGRA
systems is intended for use for the quantitative
determination of sodium, potassium, chloride
and lithium concentrations in undiluted serum
and plasma using ion-selective electrode.
ISE Indirect:
The ISE module of the COBAS INTEGRA
systems is intended for use for the quantitative
determination of sodium, potassium, chloride
concentrations in diluted serum and plasma
using ion-selective electrode.
ISE in Urine:
The ISE module of the COBAS INTEGRA
systems is intended for use for the quantitative
determination of sodium, potassium, chloride
concentrations in diluted urine using ion-
selective electrode. | 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. |
| Sample type | Serum, plasma, urine | Same |

2

| Feature | Predicate Device -- Chloride
Electrode
(approved via K963627) | Modified Chloride Electrode Gen. 2 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Electrode Information | | |
| Calibrator | ISE solutions 1,2,3
ISE Calibrator Direct
ISE Calibrator Indirect/Urine

Substantial equivalency - similarities (continued)

3

| Feature | Predicate Device – Chloride
Electrode
(approved via K963627) | Modified Chloride Electrode Gen. 2 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Endogenous
Interferences | ISE Direct and Indirect
(serum/plasma):
Hemolysis – no significant
interferences up to a hemoglobin level
of 10 g/L

Lipemia - no significant interferences

Icterus – no significant interferences | Same |
| | | |
| | | |
| | | |
| | | |
| | | |
| Exogenous
Interference | ISE Direct (serum/plasma)
Probenecid causes artificially high
chloride concentrations. | ISE Direct (serum/plasma)
Ca-Dobesilate, Phenylbutazone,
Acetylsalicylic acid and Ibuprofen
causes artificially high chloride
concentrations. |
| | Salicylic acid concentration of 1.2
mmol/L increase chloride
concentration by aprox. 10% | Same |
| | ISE Indirect (serum/plasma)
Acetylsalicylic acid causes artificial
high Chloride concentrations. | ISE Indirect(serum/plasma)
Acetylsalicylic acid and Ibuprofen
causes artificial high chloride
concentrations. |
| | ISE Urine
Drug panel tested caused no
significant interferences up to the
indicated concentrations in the label. | ISE Urine:
Ascorbic acid, Ca-Dobesilate and
Levodopa causes artificially high
chloride concentrations. |
| | | |

Substantial equivalency - similarities (continued)

4

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

5

| Feature | Predicate Device - Chloride
Electrode
(approved via K963627) | Modified Chloride Electrode Gen. 2 |
|-----------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Characteristics | | |
| ISE Indirect
mode
CV% | Within run CV% (n=20):
0.77% @ 87 mmol/L
0.72% @ 101 mmol/L | Within run CV%(n=21):
Serum:
0.65% @ 90.3 mmol/L
0.25% @ 124.1 mmol/L
Plasma:
0.29% @ 86.4 mmol/L
0.23% @ 121.9 mmol/L |
| | Between run CV% (n=20):
1.5% @ 87 mmol/L
1.2% @ 101 mmol/L | Between day CV%(n=21):
Serum:
1.0% @ 92.0 mmol/L
0.9% @ 122.8 mmol/L
Plasma:
1.1% @ 88.7 mmol/L
1.0% @ 121.6 mmol/L |
| | | Total CV%:
Serum:
1.0%@ 92.1mmol/L
1.0% @ 122.8 mmol/L
Plasma:
1.1% @ 88.8 mmol/L
1.0% @ 121.6 mmol/L |

Substantial equivalency - differences (continued)

6

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 - Chloride
Electrode | Modified Chloride Electrode Gen. 2 |
|----------------------------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| | (approved via K963627) | |
| ISE Urine
mode
CV% | Within run CV% (n=20):
0.97% @ 53 mmol/L
1.2% @ 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 run CV% (n=20):
2.8% @ 53 mmol/L
2.2% @ 267 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
(mmol/L) | ISE Direct - Serum/plasma: 20-250
ISE Indirect - Serum/plasma: 20-250
ISE Urine: 20-350 | ISE Direct -- Serum/Plasma: 60-140
ISE Indirect - Serum/Plasma: 60-140
ISE Urine: 20-250 |
| Sensitivity for
electrode:
slope | -42 to -56 mV/dec | ISE Direct: -35 to -56 mV/dec
ISE 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).

8

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

9

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