(279 days)
Not Found
No
The summary describes a coulometric titration system for measuring chloride in sweat, a standard laboratory technique. There is no mention of AI, ML, image processing, or any data analysis methods that would typically involve these technologies. The performance studies focus on precision and method comparison, not on the performance metrics associated with AI/ML models.
No.
This device is an in vitro diagnostic (IVD) test system used to measure chloride in human sweat for the diagnosis of Cystic Fibrosis. It does not treat or prevent disease, but rather provides diagnostic information.
Yes
The "Intended Use / Indications for Use" section explicitly states "The Wescor ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat... Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis." This clearly indicates its purpose as a diagnostic device.
No
The device description explicitly states it includes a "ChloroChek Chloridometer analyzer" and a "ChloroChek Reagent Set," which are physical components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The Wescor ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat..."
- Purpose: The device is used to measure a substance (chloride) in a sample taken from the human body (sweat) for the purpose of diagnosing a disease (Cystic Fibrosis). This is a core characteristic of an IVD.
- Setting: It is intended for use in "Clinical Laboratory settings," which is a typical environment for IVD testing.
- Components: The system includes both the analyzer and reagents, which are common components of IVD test systems.
The description clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Wescor ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings. The Wescor ChloroChek Chloridometer test system consists of the ChloroChek Chloridometer and the ChloroChek Reagent Set.
The ChloroChek Reagent Set (SS-248) is to be used on the ChloroChek. It is used as the titration matrix during the titration process.
The 100 mmol/L NaCl/H2O Standard Solution (SS-251), is to be used on the ChloroChek. It is used as a calibration verifier, and quality control solution.
The Wescor Sweat Controls (SS-150), levels #1, #2, and #3, are to be used on the ChloroChek. They are used as quality control solutions.
Product codes (comma separated list FDA assigned to the subject device)
JFS, JJX
Device Description
The CHLOROCHEK™ Chloridometer® test system includes the Chloro-Chek Chloridometer analyzer and the ChloroChek Reagent Set. The sys-tem is for in-vitro diagnostics intended to measure the level of chloride in human sweat. It is a bench top chloride titrator for laboratory determina-tions of chloride concentrations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Sweat, human sweat
Indicated Patient Age Range
Infant (0-6 months), Beyond Infancy (6 months-18 years), Adults (>18 years)
Intended User / Care Setting
Clinical Laboratory settings.
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)
A precision study was performed using two instruments, two lots of reagents, three operators, over 10 days on the three sweat levels, the 100mmol/L standard solution and a 10 mmol/L standard solution. The precision at the lower end of the measuring range, 10 mmol/L standard solution, was tested by 3 operators on 2 instruments with 2 reagent lots over 10 days and measured to be SD 0.6 mmol/L, 5.6% CV.
The linear range of the method (10-160 mmol/L) is compatible with the measurement of normal and pathological samples and the precision performance meets acceptance criteria. Likewise, correlation studies versus the predicate device meet acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision:
Low concentration (24mmol/L) CV=4.0%
Medium concentration (49mmol/L) CV=1.7%
High concentration (100mmol/L) CV= 1.0%
100 mmol/L standard solution CV= 1.0%
10mmol/L standard solution CV=5.6%
Method comparison: y=.9992x + 0.8754, r2= 0.9886, range tested (non-spiked and spiked): 8.0 to 642 U/L
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
MAR 27 2013
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substan- tial equivalence.
The assigned 510(k) number is: K121823 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | ELITechGroup Wescor ("Wescor") |
| Address | 370 W 1700 S, Logan, UT 84321 USA |
| Phone number | 435-752-6011 |
| Fax number | 435-752-4127 |
| Contact | Dawn T. Perdue (Email: d.perdue@elitechgroup.com) |
| Alternat Contact | Dennis Briscoe, (d.briscoe@elitechgroup.com |
| Date of Preparation | Thursday, March 21, 2013 |
| Trade/proprietary Name: | ChloroChek Chloridometer test system (containing;)
CHLOROCHEK TM Chloridometer ®1
CHLOROCHEK TM Reagent Set |
| Common or Usual Name: | Clinical chloride analyzer, Chloride test system, Sweat Chloride Analyzer,
Chloridometer ®, chloride coulometric |
| Requiation | Name | Classification | Product
ないという。
Code | Panel® |
|---------------|----------------------|----------------|---------------------------|----------------|
| 21 § 862.1170 | Chloride test system | | JFS | (75) Chemistry |
| 21 § 862.1660 | Quality Control | , reserved | JJX | (75) Chemistry |
Establishment Information:
The establishment registration number for ELITechGroup Wescor USA is 1717966. The owner operator number for ELITechGroup North America (Wescor, Logan, UT, USA) is 1717966.
1 *ChloroChek" is a registered trademark of Wescor Inc. "Chloridometer" is a registered trademark of LABCONCO that has been licensed exclusively to Wescor.
1
Predicate device:
| Predicate Instrument | 510(k) Number | |
|---|---|---|
| Buchler Instruments (Labconco), Chloridometer®. | K760394 | |
| Substantial Equivalence: | The Wescor CHLOROCHEK™ Chloridometer® test system (Model 3400 | |
| with associated reagent set (SS-248), is an in vitro diagnostic device | ||
| which has been developed by Gonotec in Germany and is currently being | ||
| OEM by. ELITechGroup Wescor. It has been demonstrated that the | ||
| CHLOROCHEK™ Chloridometer® test system is substantially equivalent | ||
| to the predicate device Buchler Instruments, Chloridometer® (now owned | ||
| by Labconco) cleared under K760394. |
Wescor ChloroChek ™ Reagent Set (SS-248) contains (a) ChloroChek ™
Acid Buffer solution, a stabilizer (SS-248ABS), (b) ChloroChek ™ Gelatin
solution (SS-248GS), and (c) Wescor Standard solution 100mmol/L
NaCl/H2O, (SS-251) which is used during the conditioning phase. | |
| Device description: | The CHLOROCHEK™ Chloridometer® test system includes the Chloro-
Chek Chloridometer analyzer and the ChloroChek Reagent Set. The sys-
tem is for in-vitro diagnostics intended to measure the level of chloride in
human sweat. It is a bench top chloride titrator for laboratory determina-
tions of chloride concentrations. | |
| Performance Standards: | To date, no performance standards that affect this device have been
finalized under Section 514 of the Act. | |
| Intended Use: | See Indications for Use | |
| Indications for Use: | The Wescor ChloroChek Chloridometer test system is intended for the quantitative
in vitro diagnostic determination of chloride in human sweat using the principle of
coulometric titration. Sweat chloride measurements are used in the diagnosis of
Cystic Fibrosis. It is for use in Clinical Laboratory settings. The Wescor Chloro-
Chek Chloridometer test system consists of the ChloroChek Chloridometer and the
ChloroChek Reagent Set.
The ChloroChek Reagent Set (SS-248), is to be used on the ChloroChek. It is used
as the titration matrix during the titration process.
The 100 mmol/L NaCl/H2O Standard Solution (SS-251), is to be used on the
ChloroChek. It is used as a calibration verifier, and quality control solution. | |
Section 5- 510(k) Summary
2
Comparison to Predicate device:
| Difference | |||
|---|---|---|---|
| Wescor | |||
| CHLOROCHEK™ Chloridometer® | |||
| test system | Predicate device | ||
| Buchler Instruments, (Labconco) | |||
| Digital Chloridometer® | |||
| Sample Type | Samples of human sweat | Manual lists sweat, serum, plasma, and | |
| urine. | |||
| Sample Size | 10 uL | 10 uL on LOW range setting | |
| 100 uL on HIGH range setting | |||
| On board stability | No on board storage. | No on board storage. | |
| Working solution in open container re- | |||
| placed each session at least daily. | Working solution good for eight hours at | ||
| room temperature. | |||
| Calibration of instrument | |||
| Frequency | Factory calibrated. Calibration is not | ||
| required by the user. Return the instru- | |||
| ment for service if the following occurs: | Factory calibrated and users can adjust if | ||
| error exceeds specifications. | |||
| 1) Not able to condition even after | |||
| electrodes have been cleaned and | |||
| or replaced. | Conditioning and control is conducted | ||
| each day. | |||
| 2) Correct quality control values | |||
| while using Sweat Control Solu- | |||
| tions (SS-150) are not achieved. | |||
| Conditioning and control steps are per- | |||
| formed whenever the WORKING | |||
| SOLUTION is replaced and thus 24hrs. | |||
| See manual for specific procedure. | |||
| Method comparison | y=.9992x + 0.8754 | ||
| r2= 0.9886 | |||
| range tested (non-spiked and spiked): 8.0 | |||
| to 642 U/L | y=0.99x +1.01 U/L | ||
| r2= 0.9966 | |||
| range: 3.70 to 671.80 U/L | |||
| Similarities | |||
| Wescor | |||
| CHLOROCHEK™ Chloridometer® | |||
| test system | Predicate device | ||
| Buchler Instruments, (Labconco) | |||
| Digital Chloridometer® | |||
| Intended use/Indications for | |||
| Use | The Wescor ChloroChek Chloridometer test | ||
| system is intended for the quantitative in vitro | |||
| diagnostic determination of chloride in human | |||
| sweat using the principle of coulometric titra- | |||
| tion. Sweat chloride measurements are used in | |||
| the diagnosis of Cystic Fibrosis. It is for use in | |||
| Clinical Laboratory settings. The Wescor | |||
| ChloroChek Chloridometer test system con- | |||
| sists of the ChloroChek Chloridometer and the | |||
| ChloroChek Reagent Set. |
The ChloroChek Reagent Set (SS-248), is to
be used on the ChloroChek. It is used as the
titration matrix during the titration process.
The 100 mmol/L NaCl/H2O Standard Solution
(SS-251), is to be used on the ChloroChek. It
is used as a calibration verifier, and quality
control solution.
The Wescor Sweat Controls (SS-150), levels
#1, #2, and #3, are to be used on the Chloro-
Chek. They are used as quality control solu-
tions. | Same,
(Manual also lists plasma, serum, and
urine.) | |
| Reagent storage | There is a ChloroChek™ Reagent Set which
contains 1 bottle of ChloroChek™ Gelatin
Solution and 37 flasks of ChloroChek™ Acid
Buffer Solution. The 1 bottle of ChloroChek™
Gelatin Solution is dispensed equally into each
of the 37 flasks of ChloroChek™ Acid Buffer
Solution to make the WORKING
SOLUTION.
Storage of ChloroChek™ Gelatin Solution is
at 50-77°F (10-25°C). The ChloroChek™
Gelatin Solution is stable until the expiry date
stated on the label.
Storage of the ChloroChek™ Acid Buffer
Solution is 50-86°F (10-30°C). The Chloro-
Chek™ Acid Buffer Solution is stable until
the expiry date stated on the label.
Storage of the WORKING SOLUTION is 50-
77°F (10-25°C). The WORKING
SOLUTION is stable for 24 hours once pre-
pared and must be prepared each day before
use with the ChloroChek™. | Similar
There are two solutions supplied with
their instrument. One is a single
bottle of Chloridometer™ Acid Re-
agent, which is a complete reagent
solution to which the sample is added
for titration. Storage of this Chlori-
dometer Acid Reagent is at room
temperature, with an expiry date that
is printed on the bottle label, The
second solution supplied is a Gelatin
Reagent which is combined with an
Acid solution and can be used as a
substitute for the Acid Reagent. The
Gelatin Reagent is stored at room
temperature and expiration date is
printed on the bottle. The combined
Gelatin Reagent plus the prepared
acid solution can be stored under
refrigeration for up to six (6) months
or kept at room temperature for eight
(8) hours. | |
| | | Similarities | |
| | Wescor
CHLOROCHEKTM Chloridometer®
test system | Predicate device
Buchler Instruments, (Labconco)
Digital Chloridometer® | |
| Resolution | 1 mmol/L over 20 second measurement duration | (Same)
1 mEq/L over a 20 second measurement duration | |
| Solution appearance | Liquid, ready to use | Same | |
| Expected values of Cl- | Infant (0-6 months)
Normal range ≤29 mmol/L
Intermediate range 30-59 mmol/L
Indicative of CF range ≥ 60 mmol/L | Same | |
| | Beyond Infancy (6 months-18 years)
Normal range ≤39 mmol/L
Intermediate range 40-59 mmol/L
Indicative of CF range ≥ 60 mmol/L | | |
| | Adults (>18 years)*
Normal range ≤39 mmol/L
Intermediate range 40-59 mmol/L
Indicative of CF range ≥ 60 mmol/L | | |
| | * Exact ranges for adults are not fully defined.
See CLSI C34-A3 for more information. | | |
| Measuring range | 10 mmol/L to 160 mmol/L | Same | |
| Precision | Total
Low concentration (24mmol/L)
CV=4.0% | not specified | |
| | Medium concentration (49mmol/L)
CV=1.7% | | |
| | High concentration (100mmol/L)
CV= 1.0% | | |
| | 100 mmol/L standard solution
CV= 1.0% | | |
| | 10mmol/L standard solution
CV=5.6% | | |
| | Similarities | | |
| | Wescor
CHLOROCHEK™ Chloridometer®
test system | Predicate device
Buchler Instruments, (Labconco)
Digital Chloridometer® | |
| Principle of operation | Coulometric titration | Same | |
| Limitation | Halides (halogens) such as fluoride, bromide, or iodide will interfere and cause an elevated reading. CLSI acknowledges this in the C34-A3 guideline. “In addition to chloride, other halides such as bromide and iodide are also detected using a Chloridometer. Therefore, if a sweat sample contains other halides in addition to chloride, they will be detected and can falsely elevate the sweat chloride result.” (1). Halides may be present in lotions or creams, so it is important that the patients’ skin is properly cleaned prior to collecting the sweat. Refer to the CLSI C34-A3 guidelines for cleaning the skin prior to pilocarpine iontophoresis. | Same | |
Section 5- 510(k) Summary
.
3
.
4
Section 5- 510(k) Summary
Wescor CHLOROCHEK™ Chloridometer®
5
Conclusion:
A precision study was performed using two instruments, two lots of reagents, three operators, over 10 days on the three sweat levels, the 100mmol/L standard solution and a 10 mmol/L standard solution. The precision at the lower end of the measuring range, 10 mmol/L standard solution, was tested by 3 operators on 2 instruments with 2 reagent lots over 10 days and measured to be SD 0.6 mmol/L, 5.6% CV.
The linear range of the method (10-160 mmol/L) is compatible with the measurement of normal and pathological samples and the precision performance meets acceptance criteria. Likewise, correlation studies versus the predicate device meet acceptance criteria.
The data demonstrate the Wescor CHLOROCHEK™ Chloridometer® test system (analyzer (Model 3400 and associated ChloroChek Reagent Set (SS-248), [K121823], are substantially equivalent to the predicate device cleared under K760394.
The data demonstrate that the system is appropriate for its intended use and does not raise new issues of safety or effectiveness.
Section 5- 510(k) Summary
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped with a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2013
Wescor, Inc. c/o Dawn T. Perdue 370 West 1700 South Logan, UT 84321
Re: K121823
Trade/Device Name: Wescor ChloroChek Chloridometer Regulation Number: 21 CFR 862.1170 Regulation Name: Chloride Test System Regulatory Class: II Product Code: JFS, JJX Dated: January 31, 2013 Received: February 14, 2013
Dear Ms. Perdue:
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 Part 801); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for
7
Page 2-Ms. Perdue
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Carol C. 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
8
Indication for Use
510(k) Number (if known): K121823
Device Name: Wescor ChloroChek Chloridometer
Indication For Use:
The Wescor ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings. The Wescor ChloroChek Chloridometer test system consists of the ChloroChek Chloridometer and the ChloroChek Reagent Set.
The ChloroChek Reagent Set (SS-248) is to be used on the ChloroChek. It is used as the titration matrix during the titration process.
The 100 mmol/L NaCl/H2O Standard Solution (SS-251), is to be used on the ChloroChek. It is used as a calibration verifier, and quality control solution.
The Wescor Sweat Controls (SS-150), levels #1, #2, and #3, are to be used on the ChloroChek. They are used as quality control solutions.
And/Or
Prescription Use × (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Ruth A. Chesler -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K121823