(327 days)
Not Found
No
The description details a standard wet chemistry analyzer and reagents, with no mention of AI or ML in the device operation, data analysis, or performance studies. The calculations are based on absorbance measurements and enzymatic reactions, which are traditional methods.
No
Explanation: This device is an in vitro diagnostic (IVD) device used for the quantitative determination of bilirubin, blood urea nitrogen, and glucose in biological samples. It provides diagnostic information but does not directly deliver therapy or treatment to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that measurements from the S-Test reagents and S40 Clinical Analyzer are "used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders," "diagnosis and treatment of certain renal and metabolic diseases," and "diagnosis and treatment of carbohydrate metabolism disorders." This indicates its role in identifying and characterizing medical conditions.
No
The device description clearly outlines a physical hardware system (S40 Clinical Analyzer) that performs wet chemistry analysis using reagent cartridges. While software is undoubtedly involved in operating the analyzer and calculating results, the device is fundamentally a hardware-based in vitro diagnostic system, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for each reagent explicitly states "For in vitro diagnostic use only."
- Intended Use: The intended use of the reagents is for the quantitative determination of analytes (bilirubin, urea nitrogen, glucose) in biological samples (serum or heparin plasma) to aid in the diagnosis and treatment of various diseases. This is a core function of IVD devices.
- Device Description: The S40 Clinical Analyzer is described as an "automatic wet chemistry system intended for use in clinical laboratories or physician office laboratories" that measures analytes in biological samples. This aligns with the description of an IVD instrument.
- Reagent Cartridge Description: The descriptions of the reagent cartridges also explicitly state they are "intended for quantitative in vitro diagnostic determination" of the respective analytes.
The entire system, consisting of the S40 Clinical Analyzer and the S-Test reagent cartridges, is designed and intended for use in performing diagnostic tests on samples taken from the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The S40 Clinical Analyzer is an automatic wet chemistry system intended for use in clinical laboratories or physician office laboratories that consists of a desktop analyzer, an operation screen that prompts the user for operation input and displays data, a unit cover, and disposable reagent cartridges. The desktop analyzer includes a single pipettor, an incubation rotor, and a multi-wavelength photometer.
The S-Test Total Bilirubin Reagent is intended for the quantitative determination of bilirubin in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Blood Urea Nitrogen Reagent is intended for the quantitative determination of urea nitrogen in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of Urea Nitrogen are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Glucose Reagent is intended for the quantitative determination of glucose in serum or heparin plasma using the S40 Clinical Analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
JFM, CDQ, CFR, CDN, JJE
Device Description
The S40 Clinical Analyzer is an automatic wet chemistry system intended for use in clinical laboratories or physician office laboratories that consists of a desktop analyzer, an operation screen that prompts the user for operation input and displays data, a unit cover, and disposable reagent cartridges. The desktop analyzer includes a single pipettor, an incubation rotor, and a multi-wavelength photometer. The analyzer can measure analytes in serum, heparin plasma, whole blood, and urine.
Once the sample is placed into the device, the analyzer pipettes the sample, pipettes the reagent, and mixes the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance, it calculates the concentration of analyte in the sample.
The S-Test total bilirubin (BIL) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of total BIL by measuring bilirubin concentration in serum or heparin plasma based on an enzymatic photometric test measuring the formation of biliverdine from bilirubin.
The S-Test blood urea nitrogen (BUN) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of BUN in serum or heparin plasma based on an enzymatic photometric test measuring the formation of NADP from NADPH.
The S-Test glucose (GLU) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of GLU in serum or heparin plasma based on an enzymatic photometric test measuring the formation of NADPH from NADP.
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
Clinical laboratories or physician office laboratories
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)
Performance data on the S-Test BIL, S-Test BUN, and S-Test GLU included precision, accuracy, and sensitivity data.
S-Test BIL:
Precision: In testing conducted at three BIL levels for 22 days, the within-run CV ranged from 0.9 to 10.7%, and total CV ranged from 5.2 to 13.3%. In precision studies at three separate Physician Office Laboratory (POL) sites and in-house over five days, the within-run CV ranged from 0.0 to 10.4% and the total CV ranged from 0.0 to 10.4%.
Accuracy: In the correlation study, 91 samples with BIL values ranging from 0.2 to 23.9 mg/dL were assayed on the S40 Clinical Analyzer using S-Test BIL reagent and a comparison method. Least-squares regression analysis yielded a correlation coefficient of 0.996, a standard error estimate of 0.5, a confidence interval slope of 0.963 to 1.125, and a confidence interval intercept of 0.00 to 0.15. In patient correlation studies at three separate POL sites using the S40 Clinical Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients ranged from 0.997 to 0.998, standard error estimates of 0.48 to 0.53, confidence interval slopes of 0.926 to 0.981, and confidence interval intercepts of 0.02 to 0.30.
S-Test BUN:
Precision: In testing at three BUN levels for 22 days, the within-run CV ranged from 1.2 to 2.3%, and total CV ranged from 6.2 to 6.6%. In precision studies at three separate POL sites and in-house over five days, the within-run CV ranged from 0.7 to 2.5% and total CV ranged from 0.9 to 2.5%.
Accuracy: In the correlation study, 94 samples with BUN values ranging from 6 to 70 mg/dL were assayed on the S40 Clinical Analyzer using S-Test BUN reagent and a comparison method. Least-squares regression analysis yielded a correlation coefficient of 0.997, a standard error estimate of 0.9, a confidence interval slope of 0.979 to 1.040, and a confidence interval intercept of 0.34 to 1.47. In patient correlation studies at four separate POL sites using the S40 Clinical Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients ranged from 0.996 to 0.997, standard error estimates of 1.11 to 1.83, confidence interval slopes of 0.922 to 1.012, and confidence interval intercepts of -2.11 to 1.30.
S-Test GLU:
Precision: In testing conducted at three GLU levels for 22 days, the within-run CV ranged from 1.4 to 1.8%, and the total CV ranged from 5.8 to 6.6%. In precision studies at three separate POL sites and in-house over five days, the within-run CV ranged from 1.1 to 2.9%, and the total CV ranged from 1.3 to 3.4%.
Accuracy: In the correlation study, 97 samples with GLU values ranging from 26 to 454 mg/dL were assayed on the S40 Clinical Analyzer using S-Test GLU and on a comparison method. Least-squares regression analysis yielded a correlation coefficient of 0.996, a standard error estimate of 7.4, a confidence interval slope of 0.994 to 1.073, and a confidence interval intercept of -10.3 to -1.87. In patient correlation studies at four separate POL sites using the S40 Clinical Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients ranging from 0.989 to 0.998, standard error estimates of 7.7 to 16.0, confidence interval slopes of 1.044 to 1.133, and confidence interval intercept of -17.5 to -2.6.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
S-Test BIL Sensitivity: The detection limit was 0.2 mg/dL.
S-Test BUN Sensitivity: The detection limit was 4.9 mg/dL.
S-Test GLU Sensitivity: The detection limit was 18 mg/dL.
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
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. 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.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Korriyo
JUN 2 4 2008
510(k) SUMMARY
| 510(k) Owner: | Alfa Wassermann Diagnostic Technology, LLC
4 Henderson Drive
West Caldwell, NJ 07006 | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dennis Taschek
Phone: 973-852-0177
Fax: 973-852-0237 | |
| Date Summary Prepared: | June 19, 2008 | |
| Device: | Trade Name: | S-Test BIL; S-Test BUN; S-Test GLU Reagent cartridge
(21 C.F.R. § 862.1110, Product code JFM; 21 C.F.R. § 862.1770, Product code CDQ; 21 C.F.R. § 862.1345, Product code CFR) |
| | Classification: | Class II |
| | Common/Classification Name: | Total bilirubin; blood urea nitrogen; glucose test systems |
| Predicate Devices: | Manufacturers for analyzer/reagent system predicates are: | |
| | 1. ACE plus ISE/ Clinical Chemistry System
ACE Total Bilirubin Reagent (K931786)
ACE BUN Reagent (K931786)
ACE GLU Reagent (K931786) | |
| | 2. Olympus AU640 Clinical Chemistry Analyzer
Total Bilirubin Reagent (K961274)
BUN Reagent (K961274)
GLU Reagent (K961274) | |
| | 3. Piccolo® xpress Chemistry Analyzer
Total Bilirubin Reagent (K942782)
BUN Reagent (K942782)
GLU Reagent (K942782) | |
| Device Description: | The S40 Clinical Analyzer is an automatic wet chemistry system intended for use in clinical laboratories or physician office laboratories that consists of a desktop analyzer, an operation screen that prompts the user for operation input and displays data, a unit cover, and disposable reagent cartridges. The desktop analyzer includes a single pipettor, an incubation rotor, and a multi-wavelength photometer. The analyzer can measure analytes in serum, heparin | |
| | plasma, whole blood, and urine. | |
| | Once the sample is placed into the device, the analyzer pipettes the sample,
pipettes the reagent, and mixes the sample and reagent together. After the
sample and reagent react in the incubator bath, the analyzer measures the
absorbance of the sample, and based on the absorbance, it calculates the
concentration of analyte in the sample. | |
| | The S-Test total bilirubin (BIL) reagent cartridge used with the S40 Clinical
Analyzer is intended for quantitative in vitro diagnostic determination of total
BIL by measuring bilirubin concentration in serum or heparin plasma based on
an enzymatic photometric test measuring the formation of biliverdine from
bilirubin. | |
| | The S-Test blood urea nitrogen (BUN) reagent cartridge used with the S40
Clinical Analyzer is intended for quantitative in vitro diagnostic determination
of BUN in serum or heparin plasma based on an enzymatic photometric test
measuring the formation of NADP from NADPH. | |
| | The S-Test glucose (GLU) reagent cartridge used with the S40 Clinical
Analyzer is intended for quantitative in vitro diagnostic determination of GLU
in serum or heparin plasma based on an enzymatic photometric test measuring
the formation of NADPH from NADP. | |
| Intended Use: | The S-Test Total Bilirubin Reagent is intended for the quantitative
determination of bilirubin in serum or heparin plasma using the S40 Clinical
Analyzer. Measurements of the levels of bilirubin, an organic compound
formed during the normal and abnormal destruction of red blood cells, are used
in the diagnosis and treatment of liver, hemolytic hematological, and metabolic
disorders, including hepatitis and gall bladder block. This test is intended for
use in clinical laboratories or physician office laboratories. For in vitro
diagnostic use only. | |
| | The S-Test Blood Urea Nitrogen Reagent is intended for the quantitative
determination of urea nitrogen in serum or heparin plasma using the S40
Clinical Analyzer. Measurements of Urea Nitrogen are used in the diagnosis
and treatment of certain renal and metabolic diseases. This test is intended for
use in clinical laboratories or physician office laboratories. For in vitro
diagnostic use only. | |
| | The S-Test Glucose Reagent is intended for the quantitative determination of
glucose in serum or heparin plasma using the S40 Clinical Analyzer. Glucose
measurements are used in the diagnosis and treatment of carbohydrate
metabolism disorders including diabetes mellitus, neonatal hypoglycemia,
idiopathic hypoglycemia, and pancreatic islet cell carcinoma. This test is
intended for use in clinical laboratories or physician office laboratories. For in
vitro diagnostic use only. | |
| Technological
Characteristics: | The S-Test BIL is a bi-reagent cartridge. Reagent 1 and Reagent 2 both
contain bilirubin oxidase (BOD) (2000-6000 U/L) and buffer. | |
| | The S-Test BUN is a bi-reagent cartridge. Reagent 1 contains: nicotinamide
adenine dinucleotide phosphate (NADPH, reduced form), carbonate buffer (pH
10), and Good's buffer (pH 6.0). Reagent 2 contains: urease (derived from
sword bean), glutamate dehydrogenase (GLDH) (derived from yeast), and
N,N-bis (2-hydroxyethyl) glycine (BICINE) buffer (pH 8.2). | |
| | The S-Test GLU is a bi-reagent cartridge. Reagent 1 contains: hexokinase
(HK) (derived from yeast), glucose-6-phosphate dehydrogenase (G-6-PDH,
derived from bacillus), nicotinamide adenine dinucleotide phosphate (NADP,
oxidized type), and magnesium acetate 2-amino-2-hydroxymethyl-1,3-
propanediol buffer (pH 9.0). Reagent 2 contains: adenosine triphosphate
disodium salt (ATP), and 2-amino-2-hydroxymethyl 1,3-propanediol buffer
(pH 9.0). | |
| Performance
Data: | Performance data on the S-Test BIL, S-Test BUN, and S-Test GLU included
precision, accuracy, and sensitivity data. | |
| | S-Test BIL | |
| | Precision: In testing conducted at three BIL levels for 22 days, the within-run
CV ranged from 0.9 to 10.7%, and total CV ranged from 5.2 to 13.3%. In
precision studies at three separate Physician Office Laboratory (POL) sites and
in-house over five days, the within-run CV ranged from 0.0 to 10.4% and the
total CV ranged from 0.0 to 10.4%. | |
| | Accuracy: In the correlation study, 91 samples with BIL values ranging from
0.2 to 23.9 mg/dL were assayed on the S40 Clinical Analyzer using S-Test BIL
reagent and a comparison method. Least-squares regression analysis yielded a
correlation coefficient of 0.996, a standard error estimate of 0.5, a confidence
interval slope of 0.963 to 1.125, and a confidence interval intercept of 0.00 to
0.15. In patient correlation studies at three separate POL sites using the S40
Clinical Analyzer and a comparative method, least-squares regression analysis
yielded correlation coefficients ranged from 0.997 to 0.998, standard error
estimates of 0.48 to 0.53, confidence interval slopes of 0.926 to 0.981, and
confidence interval intercepts of 0.02 to 0.30. | |
| | Sensitivity: The detection limit was 0.2 mg/dL. | |
| | S-Test BUN | |
| | Precision: In testing at three BUN levels for 22 days, the within-run CV ranged
from 1.2 to 2.3%, and total CV ranged from 6.2 to 6.6%. In precision studies
at three separate POL sites and in-house over five days, the within-run CV
ranged from 0.7 to 2.5% and total CV ranged from 0.9 to 2.5%. | |
| | Accuracy: In the correlation study, 94 samples with BUN values ranging from
6 to 70 mg/dL were assayed on the S40 Clinical Analyzer using S-Test BUN | |
| | reagent and a comparison method. Least-squares regression analysis yielded a correlation coefficient of 0.997, a standard error estimate of 0.9, a confidence interval slope of 0.979 to 1.040, and a confidence interval intercept of 0.34 to 1.47. In patient correlation studies at four separate POL sites using the S40 Clinical Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients ranged from 0.996 to 0.997, standard error estimates of 1.11 to 1.83, confidence interval slopes of 0.922 to 1.012, and confidence interval intercepts of -2.11 to 1.30. | |
| | Sensitivity: The detection limit was 4.9 mg/dL. | |
| | S-Test GLU | |
| | Precision: In testing conducted at three GLU levels for 22 days, the within-run CV ranged from 1.4 to 1.8%, and the total CV ranged from 5.8 to 6.6%. In precision studies at three separate POL sites and in-house over five days, the within-run CV ranged from 1.1 to 2.9%, and the total CV ranged from 1.3 to 3.4%. | |
| | Accuracy: In the correlation study, 97 samples with GLU values ranging from 26 to 454 mg/dL were assayed on the S40 Clinical Analyzer using S-Test GLU and on a comparison method. Least-squares regression analysis yielded a correlation coefficient of 0.996, a standard error estimate of 7.4, a confidence interval slope of 0.994 to 1.073, and a confidence interval intercept of -10.3 to -1.87. In patient correlation studies at four separate POL sites using the S40 Clinical Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients ranging from 0.989 to 0.998, standard error estimates of 7.7 to 16.0, confidence interval slopes of 1.044 to 1.133, and confidence interval intercept of -17.5 to -2.6. | |
| | Sensitivity: The detection limit was 18 mg/dL. | |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These data also indicate substantial equivalence to the predicate devices. | |
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wings, representing health, human services, and the department's commitment to serving the nation. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps.
Public Health Service
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Alfa Wassermann Diagnostic Technology, Inc. c/o Mr. Dennis Tascheck Vice President, Reagent & Instrument Technologies 4 Henderson Drive West Caldwell, NJ 07006
JUN 2 4 2008
Re: K072140
Trade Name: S-Test Glucose (GLU), S-Test Total Bilirubin (BIL), S-Test Blood Urca Nitrogen (BUN) Regulation Number: 21 CFR 862.1770 Regulation Name: Urea Nitrogen Test System. Regulatory Class: Class II Product Codes: CDN, JFM, CFR, JJE Dated: June 16, 2008 Received: June 17, 2008
Dear Mr. Tascheck:
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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. 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 tolloffree ne (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.v.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): K072140
Device Name: S40 Clinical Analyzer
Indication For Use:
The S40 Clinical Analyzer is an automatic wet chemistry system intended for use in clinical laboratories or physician office laboratories that consists of a desktop analyzer, an operation screen that prompts the user for operation input and displays data, a unit cover, and disposable reagent cartridges. The desktop analyzer includes a single pipettor, an incubation rotor, and a multi-wavelength photometer.
X Prescription Use (21 CFR Part 801 Subpart D) And/Or
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 & DRH, Office of Jn Vitro Diagnostic Device Evaluation and Safety (OVD)
tom getn
RC172140
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072140
7
510(k) Number (if known): K072140
Device Name: S-Test Glucose (GLU)
Indication For Use:
The S-Test Glucose Reagent is intended for the quantitative determination of glucose in serum or heparin plasma using the S40 Clinical Analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
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 Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073140
8
510(k) Number (if known): K072140
Device Name: S-Test Total Bilirubin (BIL)
Indication For Use:
The S-Test Total Bilirubin Reagent is intended for the quantitative determination of bilirubin in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use · X (21 CFR Part 801 Subpart D) And/Or
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 Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K017140
..
9
510(k) Number (if known): K072140
Device Name: S-Test Blood Urea Nitrogen (BUN)
Indication For Use:
The S-Test Blood Urea Nitrogen Reagent is intended for the quantitative determination of urca nitrogen in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of Urea Nitrogen are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
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 Diagnostic Device Evaluation and Safety (OIVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K070148