(408 days)
Not Found
No
The document describes a standard automated clinical chemistry analyzer using established methods (colorimetric, turbidimetric, ion selective electrode) and does not mention any AI or ML components.
No
This device is an in vitro diagnostic (IVD) device used to quantitatively measure various substances in serum for diagnostic purposes; it is not a therapeutic device.
Yes
The device provides quantitative measurements of various analytes (glucose, sodium, potassium, chloride) that are explicitly stated to be used in the "diagnosis and treatment" of various conditions, such as "carbohydrate metabolism disorders including diabetes mellitus," "aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance," and "cystic fibrosis and diabetic acidosis." This clearly indicates its role in aiding medical diagnosis.
No
The device description clearly outlines multiple hardware components (Sampling Arm, Reagent Arm, Reaction Station, etc.) that are integral to the device's function as a clinical chemistry analyzer. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the XL-200 Clinical Chemistry Analyzer, the JAS Glucose Reagent, and the ISE Reagent Pack are for "in vitro quantitative measurements" of various analytes (glucose, sodium, potassium, chloride) in "serum". This means they are used to test samples taken from the human body outside of the body to provide information about a person's health.
- Device Description: The description details how the analyzer and reagents work to perform these measurements on biological samples.
- Clinical Laboratory Use: The intended use and device description both state that the device is intended for "clinical laboratory use," which is a common setting for IVD devices.
- Performance Studies: The performance studies described are typical for validating the accuracy and reliability of IVD devices for clinical use.
- Predicate Device: The mention of a predicate device (Olympus AU400 Clinical Chemistry Analyzer) which is also a clinical chemistry analyzer, further supports its classification as an IVD.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The XL-200 Clinical Chemistry Analyzer is an automated, random access, computer controlled, bench top clinical chemistry analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium, and chloride in serum. This device is intended for clinical laboratory use.
The JAS Glucose Reagent in intended for the in vitro quantitative measurement of glucose in serum on the XL-200 Clinical Chemistrv Analyzer. This device is intended for clinical laboratory use. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and of pancreatic islet cell carcinoma.
The ISE Reagent Pack is intended for the in vitro quantitative measurement of sodium, potassium, and chloride concentrations in serum on the XL-200 Clinical Chemistry Analyzer. This device is intended for clinical laboratory use.
Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and 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.
Product codes
JJE, CFR, JGS, CEM, CGZ
Device Description
The XL-200 Clinical Chemistry Analyzer is an automated bench top, random access, open analyzer for clinical chemistry and immunoturbidimetric analysis on serum, urine, and other body fluids. The analyzer mainly uses colorimetric, turbidimetric, and ion selective electrode methods for analysis of samples.
The instrument includes of the following main parts;
- Sampling Arm (for sample addition to cuvettes)
- Reagent Arm (for reagent addition to cuvettes)
- Reaction Station (cuvettes)
- Sample Plate Station (for loading samples)
- Reagent Plate Station (for on board reagents)
- Photometer (for reaction analysis reading)
- Wash Station (for cleaning of reaction cuvettes)
- Electronic Boards (for controlling the open functions)
The JAS Glucose Reagent is intended for the quantitative measurement of glucose in serum on the XL-200 Clinical Chemistry Analyzer. The Reagent is a single vial liquid that is placed for use on the XL-200 Clinical Chemistry Analyzer reagent carousel. The reagent uses the enzymatic (Hexokinase/G-6-P) UV (340nm) method. This device is for clinical laboratory use.
The JAS ISE Module consists of ion selective electrodes for sodium, potassium, and chloride, a reference electrode and accessory reagents.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Photometric, Ion Selective Electrodes
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory use
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)
Glucose Performance Characteristics
- Linearity: Protocol involved 9 serial dilutions of a 500 mg/dL Glucose Standard run on the XL-200. Results yielded an acceptable Slope of 1.001 and Intercept of -0.1mg/dL, with linearity within 3mg/dL or 5% nonlinearity, validating the claimed range of 9 to 500mg/dL.
- Calibrator Traceability: Protocol included running Verichem Laboratories Matrix Plus Chemistry Reference Kit (9500) on the XL-200. Results showed accuracy test passed with a slope of 0.972, intercept of 2.1mg/dL, and error of 1.4%.
- Interferences: Protocol used serial dilutions of a high interferent sample and a spiked sample without interferent. Acceptable interference level was defined as 0.95, Slope between 0.90 and 1.10, Intercept close to 0). For Sodium (101 sample pairs, Range 103-193 mmol/L (x method) and 101-190 mmol/L (y method), R 0.9917, Slope 0.984, Intercept 2.256 mmol/L). For Potassium (90 sample pairs, Range 1.2-9.90 mmol/L (x method) and 1.1-10.0 mmol/L (y method), R 0.9954, Slope 0.999, Intercept 0.05 mmol/L). For Chloride (88 sample pairs, Range 51-140 mmol/L (x method) and 51-145 mmol/L (y method), R 0.9856, Slope 1.070, Intercept -4.3 mmol/L).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
1 5 2014
510(k) Summary
1.) Safety and effectiveness as required by 21 CFR 807.92 STATEMENT
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement 21 CFR 807,92.
2.) Submitter's / Owner of the 510(k) and Contact Information
Name: JAS Diagnostics
Address: 14100 N.W. 57th Court Miami Lakes, FL 33014
Phone: 305 418-2320 Fax: 305 418-2321
Official Correspondent David Johnston
E-mail: djohnston@jasdiagnostics.com
Date of Preparation April 14, 2014
510(k) Application Number K130915
3.) 510k Number, Device, Proprietary Name, Common Name, Purpose for Submission, Regulatory Classification, Panel, Product Code And CFR Number
| Regulation Number: | Device Description |
|---|---|
| 21CFR Sec. - 862.2160 | Discrete Photometric Chemistry Analyzer for Clinical Use |
| 21CFR Sec. - 862.1345 | Glucose Test System |
| 21CFR Sec. - 862.1665 | Sodium Test System |
| 21CFR Sec. - 862.1600 | Potassium Test System |
| 21CFR Sec. - 862.1170 | Chloride Test System |
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MOT A : YAM
Classifications:
Class II and Class I (Analyzer)
Product Codes
- JJE Analyzer, Chemistry (Photometric, Discrete), for Clinical Use
- CFR Hexokinase, Glucose
JGS - Electrode, Ion Specific, Sodium
CEM - Electrode, Ion Specific, Potassium
- CGZ Electrode, Chloride
Panel
Chemistry (75)
4.) Proprietary Name and Common Name
Trade/Proprietary Name
XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, ISE Reagent Pack
Common Name/Usual Name
XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, ISE Reagent Pack
5.) Indications for Use
The XL-200 Clinical Chemistry Analyzer is an automated, random access. computer controlled, bench top clinical chemistry analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium, and chloride in serum. This device is intended for clinical laboratory use.
The JAS Glucose Reagent in intended for the in vitro quantitative measurement of glucose in serum on the XL-200 Clinical Chemistrv Analyzer. This device is intended for clinical laboratory use. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and of pancreatic islet cell carcinoma.
The ISE Reagent Pack is intended for the in vitro quantitative measurement of sodium, potassium, and chloride concentrations in serum on the XL-200 Clinical Chemistry Analyzer. This device is intended for clinical laboratory use.
Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance.
2
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.
6.) Device Description: JAS XL-200 Clinical Chemistry Analyzer
The XL-200 Clinical Chemistry Analyzer is an automated bench top, random access, open analyzer for clinical chemistry and immunoturbidimetric analysis on serum, urine, and other body fluids. The analyzer mainly uses colorimetric, turbidimetric, and ion selective electrode methods for analysis of samples.
The instrument includes of the following main parts;
- . Sampling Arm (for sample addition to cuvettes)
- Reagent Arm (for reagent addition to cuvettes) .
- Reaction Station (cuvettes) .
- Sample Plate Station (for loading samples) .
- Reagent Plate Station (for on board reagents) .
- . Photometer (for reaction analysis reading)
- Wash Station (for cleaning of reaction cuvettes) .
- Electronic Boards (for controlling the open functions) .
7.) Substantial Equivalence Information:
- 1.) Predicate 510(k) number: K981743
- 2.) Olympus AU400 Clinical Chemistry Analyzer:
- 3.) Comparison to predicate:
| | Device Name | Device:
XL-200
Clinical Chemistry
Analyzer | Predicate Device:
OLYMPUS AU400
Clinical Chemistry
Analyzer |
|---|-------------|-----------------------------------------------------|----------------------------------------------------------------------|
| 1 | 510(k) | Pending | K981743 |
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| 2 | System Principles | ||
|---|---|---|---|
| QC/Calibration | Automatic and Manual | Automatic and Manual | |
| LIS external connectivity | YES | YES | |
| Barcode | Samples | Samples | |
| Reagents | Reagents | ||
| Re-dilution on abnormals | YES | YES | |
| 3 | Throughput | 200 test/hour | 400 test/hour |
| 400 with ISE | 800 with ISE | ||
| 4 | Principle of analysis | ||
| Mode of detection | Photometric / ISE | Photometric / ISE | |
| Analytical Methods | Endpoint, Kinetic, Ion | ||
| Selective Electrodes | Endpoint, Kinetic, Ion | ||
| Specific Electrodes | |||
| Calibration | Linear and non linear | Linear and non linear | |
| 5 | Optical | ||
| measurement unit | |||
| Measurement modes | Absorbance | Absorbance | |
| Optical modes | Bichromatic, | ||
| turbidimetric | Bichromatic, turbidimetric | ||
| Wavelengths | 340nm, 405nm, | ||
| 505nm, 546nm, | |||
| 578nm, 600nm, | |||
| 660nm, 700nm | 340nm, 380nm, 410nm, | ||
| 450 nm, 480nm, 520nm, | |||
| 540nm, 570nm, 600nm, | |||
| 660nm , 700nm, 750nm | |||
| 800nm | |||
| Linear absorbance range | 0.0 to 2.5 A | 0 to 2.5 A | |
| Light source | halogen lamp | halogen lamp | |
| Detector | Silicone photodiode | ||
| array | Silicon photodiodes | ||
| 6 | Reaction unit | ||
| Reaction cuvettes | 45 quartz semi-disposable | 88 quartz semi-disposable | |
| Reaction volume | 180 to 570 uL | 180 to 610 uL | |
| Path length | Calculated at 10mm | 10mm conversion | |
| Temperature | Room, 30°C, 37°C | Room, 30°C, 37°C | |
| 7 | Sample and | ||
| reagent unit | |||
| Reagent positions | 25 for Rgt1, 50mL | ||
| bottles | |||
| 25 for Rgt2, 20mL | |||
| bottles | 38 for Rgt1, 60mL bottles | ||
| 38 for Rgt2, 15 & 30mL | |||
| bottles | |||
| Sample positions | 39 | 48 | |
| Pipetter system | plunger, stepper motor | ||
| driven | Micro-syringe, motor | ||
| driven | |||
| Mixing | Immersion mixing by | ||
| rotating mixers | Rotating mix bar | ||
| Reagent refrigeration | YES | YES | |
| Sample dispensing | 2 - 70 microliters | 2 - 50 microliters | |
| 8 | Power | AC220V. 50 Hz or | |
| 110v, 60Hz | AC210V, 60Hz (U.S.) | ||
| 9 | Environmental | 15 to 30°C, | |
| Humidity 40 to 80% | 15 to 30°C, | ||
| Humidity 40 to 80% | |||
| conditions | Humidity 40 to 80% | Humidity 40 to 80% | |
| 10 | ISE Principle | Ion selective, direct | |
| measurement | Ion selective, direct | ||
| measurement | |||
| 11 | ISE sample type | Serum | Serum, Urine |
| 12 | Available tests | Na, K, Cl | Na, K, Cl |
| 13 | ISE calibration | Two-point and single point | Two-point and single point |
| 14 | Sample size | 70 uL | 70 uL |
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8.) Device Description: JAS Glucose Reagent
The JAS Glucose Reagent is intended for the quantitative measurement of glucose in serum on the XL-200 Clinical Chemistry Analyzer. The Reagent is a single vial liquid that is placed for use on the XL-200 Clinical Chemistry Analyzer reagent carousel. The reagent uses the enzymatic (Hexokinase/G-6-P) UV (340nm) method. This device is for clinical laboratory use.
9.) Substantial Equivalence Information:
Predicate 510(k) number: K981743
- Olympus AU400 Clinical Chemistry Analyzer, Glucose Reagent
10.) Comparison to predicate:
| Manufacturer: | JAS Diagnostics | Beckman Coulter Olympus |
|---|---|---|
| Device Name | JAS Glucose Reagent for | |
| XL-200 Clinical | ||
| Chemistry Analyzer | Olympus Glucose Reagent for | |
| Olympus AU 400 & 600 | ||
| series Chemistry Analyzers | ||
| JAS Diagnostics | Beckman Coulter (Olympus) | |
| FDA 510k # | K130915 (CFR) | |
| (Pending) | K981743 (CFR) | |
| Classification | Moderate | |
| (Pending) | Moderate |
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| Intended Use | quantitative measurement
of glucose in serum
on the XL-200 Clinical
Chemistry analyzer
For clinical laboratory use | quantitative measurement
of glucose in serum, plasma
urine, on Beckman Coulter
clinical chemistry analyzers
For clinical laboratory use |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | enzymatic (Hexokinase /
G-6-P), UV (340nm) | enzymatic (Hexokinase /
G-6-P), UV (340nm) |
| Reagent Description | Single vial liquid reagent | Two vial liquid reagent |
| Normal Range
Adult | 74 - 106 mg/dL | 70 - 105 mg/dL |
11.) Performance Characteristics - Glucose .
Linearity
Protocol: 9 Serial Dilutions of a 500 mg/dL Glucose Standard were prepared and run on the XL-200, along with the 500 mg/dL stock Standard. Results were then plotted as a regression graph against theoretical recovery.
Results: Acceptable Slope 1.001 and Intercept of -0.1mg/dL, and data linear within allowable nonlinearity of 3mg/dL or 5% resulted; validating the product's claimed linearity range of 9 to 500mg/dL.
Calibrator Traceability:
Protocol: Verichem Laboratories Matrix Plus Chemistry Reference Kit (9500) five level reference material was run on the XL-200 Clinical Chemistry Analyzer, using JAS Glucose Reagent. This material is "Verified and lot certified using available standard reference materials for the National Institute of Standards and Technology (NIST)."
Results:
Program's Evaluation of glucose Results states accuracy test passed and results linear; with a slope of 0.972 and intercept of 2.1mg/dL, with error of 1.4%.
Interferences
Protocol: Serial dilutions were prepared using a high interferent sample material, with the same sample material (glucose level) without the interferent spiked. Acceptable interference level is the is the highest interferent sample level were the glucose values remains within 10% of the sample value unspiked with the intereferent.
Results: The following highest interferent levels for the sample, with 0.95, Slope between 0.90 and 1.10, and intercept close to 0 mg/dL level.
JAS Glucose reagent on the XL-200 Clinical Chemistry Analyzer versus Olympus glucose reagent of Olympus 400:
| Number of sample pairs: | 103 |
|---|---|
| Range tested: x method | 11 to 497 mg/dL |
| y method | 9 to 501 mg/dL |
| Corr. Coef. (R) | 0.9970 |
| Slope | 1.002 |
| Intercept | 1.8 mg/dL |
Precision/Reproducibility:
Protocol: Precision was performed using "EP Evaluator's NCCLS EP5-T2 Precision document (NCCLS.EP5)" program. Three glucose sample levels were run 20 times in duplicate, using 20 runs over a 20 day period on the XL-200 Clinical Chemistry Analyzer, for within run and for total imprecision calculation/determination.
Results: Results were entered into Rhoads EP Evaluator Software for determining precision S.D. and CV levels. All results below meet requirement of CV (%) 0.95, Slope between 0.90 and 1.10, and intercept close to 0 mg/dL level
Sodium
| Number of sample pairs: | 101 |
|---|---|
| Range tested: x method | 103 to 193 mmol/L |
| Range tested: y method | 101 to 190 mmol/L |
| Correlation Coefficient | 0.9917 |
| Slope: | 0.984 |
| Intercept: | 2.256 mmol/L |
Potassium
| Number of sample pairs: | 90 |
|---|---|
| Range tested: x method | 1.2 to 9.90 mmol/L |
| Range tested: y method | 1.1 to 10.0 mmol/L |
| Correlation Coefficient | 0.9954 |
| Slope: | 0.999 |
| Intercept: | 0.05 mmol/L |
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Chloride
88 Number of sample pairs: 51 to 140 mmol/L Range tested: x method Range tested: y method 51 to 145 mmol/L Correlation Coefficient 0.9856 Slope: 1.070 - 4.3 mmol/L Intercept:
The submitted information in this pre-market notification is complete and supports a substantial equivalence decision.
I .
14
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/14/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MI) 20993-00002
May 15, 2014
JAS DIAGNOSTICS. INC. DAVID JOHNSTON VP. RESEARCH AND DEVELOPMENT 14100 N.W. 57TH COURT MIAMI LAKES FL 33014
Re: K130915 Trade/Device Name: JAS Glucose Reagent ISE Reagent Pack XL-200 Clinical Chemistry Analyzer Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CFR, JGS. CEM. CGZ. JJE Dated: April 30, 2014 Received: May 2. 2014
Dear Mr. David Johnston:
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 docs 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 (OS) regulation (21 CFR Part 820); and if applicable, the
15
Page 2-Mr. David Johnston
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 regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-five 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" (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.lda.gov/MedicalDevices/Safety/ReportalProblem/defiult.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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
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
16
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K130915
Device Name
XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, ISE Reagent Pack
Indications for Use (Describe)
The XL-200 Clinical Chemistry Analyzer is an automated random access, computer controlled, bench top, clinical analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium and chloride in serum. This device is intended for clinical laboratory use.
The JAS Glucose Reagent is intended for the in vitro quantitative measurement of glucose in serum on the XL-200 clinical chemistry analyzer. This device is intended for clinical laboratory use. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and of pancreatic islet cell Carcinoma.
The ISE Reagent Pack is intended for the in vitro quantitative measurement of sodium, and chloride concentrations in serum on the XL-200 clinical chemistry analyzer. This device is intended for clinical laboratory use.
Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY :
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
. .
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