(536 days)
Not Found
No
The device description and performance studies focus on chemical reagents and their use with a standard clinical chemistry analyzer. There is no mention of AI or ML in the intended use, device description, or performance evaluation sections. The data analysis methods described (Deming regression, non-parametrical statistics) are standard statistical techniques, not indicative of AI/ML.
No
Explanation: The device is a set of reagents used for in vitro diagnostic measurements of various analytes in serum and urine. It aids in the diagnosis and treatment of diseases by providing quantitative measurements, but it does not directly treat or prevent a disease, injury, or condition in a patient.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the measurements provided by these reagents are "used in the diagnosis and treatment of numerous diseases." This directly indicates a diagnostic purpose.
No
The device described is a set of chemical reagents for in vitro diagnostic testing, not a software-only medical device. It is used in conjunction with a clinical chemistry analyzer (hardware).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these reagents are for the "quantitative measurement of [analyte] in serum [and/or urine]" and that these measurements are "used in the diagnosis and treatment of numerous diseases". This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The description further clarifies that these are "test systems for the quantitative measurement of [analytes] in human serum and urine". This confirms they are used to test biological samples.
- Performance Studies: The performance studies described (Method Comparison, Reportable Range, Sensitivity, Interferences, Stability, Precision) are typical studies conducted to validate the performance of an IVD device.
- Predicate Devices: The mention of predicate devices with K numbers indicates that these reagents are being compared to previously cleared IVD devices.
Therefore, based on the provided information, the Medicon Hellas reagents for Albumin, Calcium, Creatinine, Glucose, Direct Bilirubin, Total Bilirubin, and Urea Nitrogen are indeed In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Medicon Hellas Albumin: Reagent for the quantitative measurement of albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Medicon Hellas Calcium: Reagent for the quantitative measurement of calcium in serum or urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Medicon Hellas Creatinine: Reagent for the quantitative measurement of creatinine in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
Medicon Hellas Glucose. Reagent for the quantitative measurement of glucose in serum and urine. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Medicon Hellas Direct Bilirubin; Reagent for the quantitative measurement of direct bilirubin (conjugated) in serum. Measurements of the level of direct bilirubin is used in the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall blader block.
Medicon Hellas Total Bilirubin; Reagent for the quantitative measurements of total bilirubin in serum. Measurements of the levels of total bilirubin is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Medicon Hellas Urea Nitrogen: Reagent for the quantitative measurement of urea nitrogen in serum and urine. Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
Product codes
CIX, CDQ, CJY, CGX, CIG, CFR
Device Description
Medicon Hellas Albumin: The BCG method is applied on serum samples, without serum blank. The bi-chromatic photometric determination of albumin is based on albumin binding the anionic dye bromocresol green in mildly acidic pH. The raise in absorbance at 620/750 nm is proportional to the concentration of albumin in the sample. The sample volume used for the assay is 2uL.
Medicon Hellas Calcium: Calcium ions react with Arsenazo III dye in acidic pH, to form a violet complex. The absorbance at 650/750 nm is proportional to the concentration of calcium in serum or urine samples. The analyzer photometer reads the absorbance at time intervals dictated by the method application stored in the analyzer memory, and the change in absorbance is calculated automatically. The sample volume used by the assay is 2uL for serum or urine samples.
Medicon Hellas Creatinine: Creatinine forms a yellow-orange complex with picrate anions in alkaline medium. The rate of change of absorbance of the complex at 505/700 nm is proportional to creatinine concentration in serum or urine samples. The sample volume used by the assay is 22uL for serum and urine samples.
Medicon Hellas Glucose: Glucose (Hexokinase) The determination of glucose is according to the hexokinase method based on the following reactions using 2uL of sample for serum and urine samples. The concentration of glucose is determined bi-chromatically by the absorbance change at 340/380 nm. Hexokinase Glucose + ATP 6-phosphate glucose + ADP 6-phosphate glucose + NAD
Medicon Hellas Direct Bilirubin: The modified Malloy-Evelyn method is applied on serum samples. Direct (conjugated) bilirubin reacts with diazotised sulfanilic acid in acidic pH to form azobilirubin, a colored chromophore. The absorbance of chromophore at 550/650 nm is proportional to the concentration of direct bilirubin in the sample. The free (unbound) bilirubin fraction does not react. The reaction is an end-point type. The sample volume used by the assay is 8uL.
Medicon Hellas Total Bilirubin: The DPD method is applied, whereby 3,5-dichlorophenyldiazonium tetrafluoroborate (DPD) binds directly to total bilirubin in acidic medium, forming azobilirubin, whose rate of absorbance at 550/700 nm is proportional to the concentration of total bilirubin in serum samples. The analyzer photometer reads the absorbance at time intervals dictated by the method application stored in the analyzer memory, and the change in absorbance is calculated automatically. The sample volume used by the assay is 20uL.
Medicon Hellas Urea Nitrogen: Medicon Hellas Urea Nitrogen is an in vitro diagnostic assay for the quantitative determination of urea nitrogen in human serum and urine. Urea Nitrogen is determined according to the following reactions, using 7uL of sample for serum and urine samples: Urease Urea Nitrogen + H2O ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ 2NH3 + CO2 GLDH 2NH4+ + 2-a-Ketoglutarate + 2NADH -2-L-Glutamate + 2NAD+ 2H2O 1 The rate of absorbance change at 340/380 nm is proportional to the urea nitrogen concentration in the sample. For all assays the analyzer photometer reads the absorbances at time intervals dictated by the method application stored in the analyzer memory, and the change in absorbance is calculated automatically.
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 labs
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)
Method Comparison: Accuracy testing was run simultaneously in blind fashion with the candidate and predicate devices. A minimum of 70 clinical specimens, spanning the dynamic ranges, were assayed in singleton and in a blinded fashion on at least three lots of each candidate system and on a representative lot of each predicate device. Results were tabulated and evaluated using Analyse-it software to generate Deming regression statistics. Key Results: Accuracy studies completed on at least three lots of each candidate reagent confirm that Medicon albumin, calcium, creatinine, glucose, total bilirubin and urea nitrogen are substantially equivalent to the related predicate devices - Beckman Coulter AU reagents used on the AU2700 analyzer. Medicon direct bilirubin reagent used with a Diatron Pictus 500 analyzer is substantially equivalent to its predicate device - Abbott Architect c8000 direct bilirubin used with the Architect c8000 analyzer.
Reportable Range (Linearity): Statistical analysis is performed at a 5% level of significance and the evaluation is according to CLSI EP06-A. At least nine levels of each sample type were tested with at least three lots of the corresponding Medicon reagents. The samples were assigned their reference values arithmetically from serial dilutions of the high-level sample. Each level was tested N=4 on the Pictus P500. Results from each level were averaged. All statistics were calculated using Analyse-it Software. Key Results: The combined data from various lots of each of the Medicon candidate reagents used with the Pictus 500 chemistry analyzers met statistical acceptance criteria. Reportable ranges were comparable to the predicate device reportable ranges.
Sensitivity (LOD/LOQ): Medicon completed sensitivity studies following CLSI EP17-A2. LoB was calculated using non-parametrical statistics and LoD was calculated from LoB following equation LoD = LoB+1.654*SD. LoB/LoD were determined using: 5 Blank samples and 5 Low Levels samples respectively which were measured 4 times each day for a total of 60 measurements in 3 days. LoQ: 10 samples that span the low end of linearity were measured 5 times each day for a total of 150 measurements in 3 days. LoQ was calculated until a specific concentration generated a CV of
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 21, 2021
Medicon Hellas, S.A. Sotia Mitropoulos Regulatory Manager Melitona 5-7, 153 44, Gerakas, Greece
Re: K200898
Trade/Device Name: Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Direct Bilirubin, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Urea Nitrogen Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin Test System Regulatory Class: Class II Product Code: CIX, CDQ, CJY, CGX, CIG, CFR Dated: February 24, 2021 Received: February 24, 2021
Dear Sotia Mitropoulos:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-torres -S
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200898
Device Name
Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin and Medicon Hellas Urea Nitrogen.
Indications for Use (Describe)
Medicon Hellas Albumin: Reagent for the quantitative measurement of albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Medicon Hellas Calcium: Reagent for the quantitative measurement of calcium in serum or urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Medicon Hellas Creatinine: Reagent for the quantitative measurement of creatinine in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
Medicon Hellas Glucose. Reagent for the quantitative measurement of glucose in serum and urine. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Medicon Hellas Direct Bilirubin; Reagent for the quantitative measurement of direct bilirubin (conjugated) in serum. Measurements of the level of direct bilirubin is used in the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall blader block.
Medicon Hellas Total Bilirubin; Reagent for the quantitative measurements of total bilirubin in serum. Measurements of the levels of total bilirubin is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Medicon Hellas Urea Nitrogen: Reagent for the quantitative measurement of urea nitrogen in serum and urine. Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510k (K200898) safety and effectiveness information is re-submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 807.92 (a)(1): Name: | MEDICON HELLAS S.A. |
|---|---|
| Address: | Melitona 5-7, 153 44 Gerakas, Greece |
| Phone: | +302.1.0660.6000 |
| FAX: | +302.1.0661.2666 |
| Contact: | Ms. Sotia Mitropoulos |
| Email: | mitropoulos@mediconsa.com |
| US Agent: | Diatron US, Inc. |
| 1.833.228.7931 | |
| Mr. Frank Matuszak | |
| frank.matuszak@diatron.com |
807.92 (a)(2): Device name- trade name and common name, and classification
Trade Name: Medicon Hellas Albumin. Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Glucose, Medicon Hellas Direct Bilirubin, Medicon Hellas Total Bilirubin, and Medicon Hellas Urea Nitrogen, for use with Diatron Pictus 500 Clinical Chemistry Analyzers.
Common Name: test systems for albumin, calcium, creatinine, glucose, direct and total bilirubin and urea nitrogen for testing human serum and urine where clinically applicable.
Classification Name(s):
21 CFR § 862.1035 - Albumin Test system - Class II- Product Code CIX
21 CFR § 862.1145 - Calcium Test system - Class II- Product Code CJY
21 CFR § 862.1225 - Creatinine Test system - Class II- Product Code CGX
21 CFR & 862.1110 - Direct Bilirubin Test system - Class II- Product Code CIG
21 CFR § 862.1345 - Glucose Test system - Class II- Product Code CFR
21 CFR § 862.1110 - Total Bilirubin Test system - Class II- Product Code CIG
21 CFR § 862.1770 - Urea Nitrogen Test system - Class II- Product Code CDQ
4
807.92 (a)(3): Identification of the legally marketed predicate devices
- 21 CFR § 862.1035 Albumin Test system Class II-Beckman Coulter Albumin (K924368)
- 21 CFR § 862.1145 Calcium Test system Class II-Beckman Coulter Calcium (K061575)
- 21 CFR & 862.1225 Creatinine Test system- Class II-Beckman Coulter Creatinine (K934361)
- 21 CFR § 862.1345 Glucose Test system Class II-Beckman Coulter Glucose (K944406)
- 21 CFR & 862.1110 Direct Bilirubin Test system Class II-Abbott Architect Direct Bilirubin (K022180)
- 21 CFR § 862.1110 Total Bilirubin Test system Class II-Beckman Coulter Total Bilirubin (K924964)
- 21 CFR & 862.1770 Urea Nitrogen Test system Class II-Beckman Coulter Urea Nitrogen (BUN) (K944250)
807.92 (a)(4): Device Description
Medicon Hellas Albumin:
The BCG method is applied on serum samples, without serum blank. The bi-chromatic photometric determination of albumin is based on albumin binding the anionic dye bromocresol green in mildly acidic pH. The raise in absorbance at 620/750 nm is proportional to the concentration of albumin in the sample. The sample volume used for the assay is 2uL.
Medicon Hellas Calcium:
Calcium ions react with Arsenazo III dye in acidic pH, to form a violet complex. The absorbance at 650/750 nm is proportional to the concentration of calcium in serum or urine samples. The analyzer photometer reads the absorbance at time intervals dictated by the method application stored in the analyzer memory, and the change in absorbance is calculated automatically. The sample volume used by the assay is 2uL for serum or urine samples.
Medicon Hellas Creatinine:
Creatinine forms a yellow-orange complex with picrate anions in alkaline medium. The rate of change of absorbance of the complex at 505/700 nm is proportional to creatinine concentration in serum or urine samples. The sample volume used by the assay is 22uL for serum and urine samples.
5
Medicon Hellas Glucose: Glucose (Hexokinase)
The determination of glucose is according to the hexokinase method based on the following reactions using 2uL of sample for serum and urine samples. The concentration of glucose is determined bi-chromatically by the absorbance change at 340/380 nm.
Hexokinase Glucose + ATP 6-phosphate glucose + ADP 6-phosphate glucose + NAD
Medicon Hellas Direct Bilirubin :
The modified Malloy-Evelyn method is applied on serum samples. Direct (conjugated) bilirubin reacts with diazotised sulfanilic acid in acidic pH to form azobilirubin, a colored chromophore. The absorbance of chromophore at 550/650 nm is proportional to the concentration of direct bilirubin in the sample. The free (unbound) bilirubin fraction does not react. The reaction is an end-point type. The sample volume used by the assay is 8uL.
Medicon Hellas Total Bilirubin:
The DPD method is applied, whereby 3,5-dichloropheny|diazonium tetrafluoroborate (DPD) binds directly to total bilirubin in acidic medium, forming azobilirubin, whose rate of absorbance at 550/700 nm is proportional to the concentration of total bilirubin in serum samples. The analyzer photometer reads the absorbance at time intervals dictated by the method application stored in the analyzer memory, and the change in absorbance is calculated automatically. The sample volume used by the assay is 20uL.
Medicon Hellas Urea Nitrogen:
Medicon Hellas Urea Nitrogen is an in vitro diagnostic assay for the quantitative determination of urea nitrogen in human serum and urine. Urea Nitrogen is determined according to the following reactions, using 7uL of sample for serum and urine samples:
Urease Urea Nitrogen + H2O ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ 2NH3 + CO2 GLDH 2NH4+ + 2-a-Ketoglutarate + 2NADH -2-L-Glutamate + 2NAD+ 2H2O 1
The rate of absorbance change at 340/380 nm is proportional to the urea nitrogen concentration in the sample.
For all assays the analyzer photometer reads the absorbances at time intervals dictated by the method application stored in the analyzer memory, and the change in absorbance is calculated automatically.
6
807.92 (a)(5): Intended Use
Medicon Hellas Albumin: Reagent for the quantitative measurement of albumin in serum. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Medicon Hellas Calcium: Reagent for the quantitative measurement of calcium in serum or urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Medicon Hellas Creatinine: Reagent for the quantitative measurement of creatinine in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
Medicon Hellas Glucose: Reagent for the quantitative measurement of glucose in serum and urine. 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.
Medicon Hellas Direct Bilirubin; Reagent for the quantitative measurement of direct bilirubin (conjugated) in serum. Measurements of the level of direct bilirubin is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall blader block.
Medicon Hellas Total Bilirubin: Reagent for the quantitative measurements of total bilirubin in serum. Measurements of the levels of total bilirubin is used in the diagnosis and treatment of liver. hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Medicon Hellas Urea Nitrogen: Reagent is for the quantitative measurement of urea nitrogen in serum and urine. Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
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| Characteristic | Candidate- Medicon Hellas
(Medicon) reagents | Predicate- Beckman Coulter (BC) AU
Reagents run on the BC AU2700
analyzer | Predicate- Abbott Diagnostics (AD)
Direct Bilirubin run on the Architect
c8000 analyzer |
|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Mode of Detection | Photometric | Same | Same |
| Photometric Detector | Photodiode | Same | Same |
| Optical Modes | Monochromatic, Bi-chromatic,
Turbidimetric | Same | Same |
| Analytical Measure | Endpoint and kinetic with sample
blanking | Same | Same |
| Wavelengths | 12 (340 - 750nm) | 13 (340 - 800nm) | 16 (340 - 804nm) |
| Linear Absorbance Range | -0.1 to 3.6 | 0.0 to 3.0 | -0.1 to 3.2 |
| Device Class, Regulation Code, Product
Code | Class I, 21 CFR 862.2160 (discrete
photometric chemistry analyzer), JJE | Same | Same |
| Reagent Platform | Candidate- Medicon Hellas reagents | Predicate - Beckman Coulter AU
Reagents | Predicate - Abbott Diagnostics Direct
Bilirubin reagent |
| | Albumin | Albumin (K924368) | |
| | Calcium | Calcium (K061575) | |
| | Creatinine (picrate based) | Creatinine (K934361) | |
| Test Systems | Glucose | Glucose (K944406) | |
| | Direct Bilirubin | N/A | Direct Bilirubin (K022180) |
| | Total Bilirubin | Total Bilirubin (K924964) | |
| | Urea Nitrogen | Urea Nitrogen (K944250) | |
| | Albumin- 21 CFR § 862.1035, CIX | Same | |
| | Calcium- 21 CFR § 862.1145, CJY | Same | |
| | Creatinine- 21 CFR § 862.1225, CGX | Same | |
| Device Class II, Regulation Code,
Classification Product Code | Glucose- 21 CFR § 862.1345, CFR | Same | |
| | Direct Bilirubin- 21 CFR § 862.1110, CIG | | Same |
| | Total Bilirubin-21 CFR § 862.1110, CIG | Same | |
| | Urea Nitrogen - 21 CFR § 862.1770, CDQ | Same | |
| Intended Use | Quantitative determinations of albumin,
calcium, creatinine, direct bilirubin,
glucose, total bilirubin and urea with
serum or urine samples where clinically
applicable. | Quantitative determinations of albumin,
calcium, creatinine, glucose, total bilirubin
and urea with serum or urine samples
where clinically applicable. | Quantitative determinations of direct
bilirubin on human serum samples. |
| Testing Environment | Clinical labs | Same | Same |
| Method Principle | Photometry | Same | Same |
| Specimen Type | Human serum, and urine if applicable | Same | Same |
807.92 (a)(6): Technological Similarities and Differences to the Predicates
8
807.92 (b)(1,2): Brief Description of Nonclinical and Clinical Data
Medicon Hellas (Medicon) has performed a series of studies to confirm the substantial equivalence of their test systems to the predicate devices. Results from each candidate test system were found to be substantially equivalent to their related predicate device. The predicate device used for Medicon Albumin, Medicon Calcium, Medicon Creatinine, Medicon Total Bilirubin and Medicon Urea Nitrogen (BUN) was the Beckman Coulter (BC) AU 2700 analyzer using the corresponding AU reagents. The predicate device for Medicon Direct Bilirubin was the Abbott Diagnostics Architect c8000 analyzer using its corresponding reagent.
Two to three lots of each candidate device were used for the studies. Testing confirmed equivalent performance of the candidate systems to the corresponding predicate devices.
Studies included accuracy (method comparison), reportable range (linearity), sensitivity (limit of quantification), precision including: repeatability, within run, between run and within lab (total), interfering endogenous and exogenous substances, reagent on-board stability and calibration frequency. The following provide performance summary information from the studies for each candidate reagent. The following summarize the type and scope of testing completed for each candidate device. Following this section, the data for each of the candidate devices is provided.
Method Comparison- The protocol followed was according to CLSI EP09c: accuracy testing was run simultaneously in blind fashion with the candidate and the predicate devices. A minimum of 70 clinical specimens, spanning the dynamic ranges, were assayed in singleton and in a blinded fashion on the at least three lots of each candidate system and on a representative lot of each predicate device. Results were tabulated and evaluated using Analyse-it software to generate Deming regression statistics.
Summary: Accuracy studies completed on at least three lots of each candidate reagent confirm that Medicon albumin, calcium, creatinine, glucose, total bilirubin and urea nitrogen are substantially equivalent to the related predicate devices - Beckman Coulter AU reagents used on the AU2700 analyzer. Medicon direct bilirubin reagent used with a Diatron Pictus 500 analyzer is substantially equivalent to its predicate device - Abbott Architect c8000 direct bilirubin used with the Architect c8000 analyzer.
Reportable Range - Linearity - Statistical analysis is performed at a 5% level of significance and the evaluation is according to CLSI EP06-A. At least nine levels of each sample types were tested with at least three lots of the corresponding Medicon reagents. The samples were assigned their reference values arithmetically from serial dilutions of the high-level sample. Each level was tested N=4 on the Pictus P500. results from each level were averaged. All statistics were calculated using Analyse-it Software.
Summary: the combined data from various lots of each of the Medicon candidate reagents used with the Pictus 500 chemistry analyzers met statistical acceptance criteria. Reportable ranges were comparable to the predicate device reportable ranges.
9
Sensitivity (LOD/LOQ) - Medicon completed sensitivity studies following CLSI EP17-A2. LoB was calculated using non-parametrical statistics and LoD was calculated from LoB following equation LoD = LoB+1.654*SD:
LoB/LoD were determined using: 5 Blank samples and 5 Low Levels samples respectively which were measured 4 times each day for a total of 60 measurements in 3 days.
LoQ: 10 samples that span the low end of linearity were measured 5 times each day for a total of 150 measurements in 3 days. LoQ was calculated until a specific concentration generated a CV of