Who is the manufacturer of S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU?

Alfa Wassermann Diagnostic Technologies, Inc. filed the 510(k) submission for S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU (K072140).

What is the FDA product code for S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU?

CFR. It is classified under 21 CFR 862.1345 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU?

510(k) clearance (submission type: Traditional).

What are the predicate devices for S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU?

ACE plus ISE/Clinical Chemistry System, Alfa Wassermann (k930104).

Who can help prepare an FDA 510(k) submission like S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU

K072140 · Alfa Wassermann Diagnostic Technologies, Inc. · CFR · Jun 24, 2008 · Clinical Chemistry

Device Facts

Record ID	K072140
Device Name	S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU
Applicant	Alfa Wassermann Diagnostic Technologies, Inc.
Product Code	CFR · Clinical Chemistry
Decision Date	Jun 24, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1345
Device Class	Class 2

Intended 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 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 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 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.

Device Story

S40 Clinical Analyzer is an automatic wet chemistry system for clinical/physician office labs; utilizes disposable reagent cartridges containing specific enzymes (urease, bilirubin oxidase, hexokinase). Input: serum or heparin plasma samples. Operation: single pipettor transfers sample to incubation rotor; multi-wavelength photometer measures absorbance changes (NADPH or biliverdine formation). Output: quantitative concentration values displayed on operation screen. System identifies assays via 2D barcode on cartridges. Healthcare providers use results to diagnose/treat renal, metabolic, liver, and carbohydrate disorders. Benefits: automated, rapid, point-of-care-capable chemistry analysis.

Clinical Evidence

Bench testing only. Precision studies (in-house and POL sites) showed total CVs generally <7%. Linearity confirmed across reportable ranges (BUN 4.9-75.7 mg/dL; BIL 0.2-26.6 mg/dL; GLU 18-472 mg/dL). Method comparison against predicate (ACE/Olympus) yielded high correlation (r > 0.99) across all analytes. Interference studies defined limits for hemolysis, lipemia, and bilirubin.

Technological Characteristics

Desktop wet chemistry analyzer; multi-wavelength photometer; single pipettor; incubation rotor. Reagents: enzymatic (urease, bilirubin oxidase, hexokinase). Connectivity: 2D barcode reader for lot-specific calibration. Traceability: NIST SRM 912a, 916a, 917a. Software: automated analysis of absorbance rates.

Indications for Use

Indicated for quantitative determination of total bilirubin, blood urea nitrogen (BUN), and glucose in serum or heparin plasma. Used for diagnosis and treatment of liver, hemolytic, metabolic, renal, and carbohydrate metabolism disorders (e.g., diabetes, hypoglycemia, hepatitis). Intended for clinical or physician office laboratory use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

ACE plus ISE/Clinical Chemistry System, Alfa Wassermann (k930104)

Related Devices

K042169 — STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER · Stanbio Laboratory · Mar 14, 2005

Submission Summary (Full Text)

{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. | | {1}------------------------------------------------ {2}------------------------------------------------ {3}------------------------------------------------ {4}------------------------------------------------ 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). {5}------------------------------------------------ Page 2 - 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