(176 days)
No
The summary describes standard clinical chemistry reagents and their performance on a photometric analyzer. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device, ABX PENTRA 400 Clinical Chemistry Analyzer reagents, calibrators, and controls, is an in vitro diagnostic (IVD) device used for quantitative determination of various analytes in human serum and plasma for diagnostic purposes, not for direct therapeutic use.
Yes
The device is described as an "in vitro diagnostic determination" for various analytes, which are used in the "diagnosis and treatment" of specific diseases. This explicitly states its role in diagnosis.
No
The device description explicitly states that the submission includes reagents, controls, and calibrators for use on a clinical chemistry analyzer, which are physical components, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the reagents, calibrators, and controls are "for quantitative in vitro diagnostic determination" of various analytes in human serum and plasma. This directly aligns with the definition of an In Vitro Diagnostic device, which is intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
Furthermore, the "Device Description" section also states that "All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters."
These statements clearly indicate that the device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The ABX PENTRA CO₂ Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CO2 RTU method as specified in the enclosed annex.
Product codes (comma separated list FDA assigned to the subject device)
CJE, CIC, KHS, CGX, JIY, JGJ, CEO, CDQ, KNK, JJX, JJY, JIX, JJT
Device Description
All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX PENTRA 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module).
All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters
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
Not Found
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)
The document provides detailed stability and correlation data for each reagent (ABX PENTRA ALP CP, ABX PENTRA Calcium CP, ABX PENTRA CO₂ RTU, ABX PENTRA Creatinine CP, ABX PENTRA Iron CP, ABX PENTRA Magnesium RTU, ABX PENTRA Phosphorus CP, ABX PENTRA Urea CP, ABX PENTRA Uric Acid CP), and stability data for calibrators and controls (ABX PENTRA CO2 Cal, ABX PENTRA Multical, ABX PENTRA CO2 Control, ABX PENTRA N Control, ABX PENTRA P Control).
Key results for reagents include:
- Sample type: Serum & plasma for all reagents.
- Detection limit: Values specified for each reagent.
- Accuracy and Precision: CV Total specified for each reagent (e.g., CV Total
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.
0
Premarket Notification [510(k)] Summary
JUL 2 1 2006
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
K060205 The assigned 510(k) number is : _
Company: Horiba ABX Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE Telephone: + (33) 4 67 14 73 20 + (33) 4 67 14 15 17 Fax:
Contact Person: Tim Lawton (tlawton@fr.abx.fr)
Date Prepared: 20th January 2006
Device Names:
The following reagents, controls & calibrators are for use in conjunction with the ABX PENTRA 400, cleared to market under K052007.
REAGENTS :
| Trade/Proprietary Name: | ABX PENTRA ALP CP |
|---|---|
| Common or Usual Name: | ALP - Alkaline phosphatase |
| Device Class | Class II |
| Classification Name: | §862.1050 : Alkaline phosphatase Test System |
| Product Code: | CJE ; nitrophenylphosphate, alkaline phosphatase or isoenzymes |
| Trade/Proprietary Name: | ABX PENTRA Calcium CP |
| Common or Usual Name: | Calcium |
| Device Class | Class II |
| Classification Name: | §862.1145 : Calcium Test System |
| Product Code: | CIC ; cresolphthalein complexone, calcium |
| Trade/Proprietary Name: | ABX PENTRA CO2 RTU |
| Common or Usual Name: | carbon dioxide |
| Device Class | Class II |
| Classification Name: | §862.1160 : Bicarbonate/carbon dioxide Test System |
| Product Code: | KHS ; enzymatic, carbon-dioxide |
1
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
Trade/Proprietary Name:
Common or Usual Name: Device Class Classification Name: Product Code:
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
CONTROLS :
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA Creatinine CP
Creatinine Class II §862.1225 : Creatinine Test System CGX : alkaline picrate, colorimetry, creatinine
ABX PENTRA Iron CP
Iron Class I §862.1410 : Iron (non-heme) Test System JIY ; photometric method, iron (non-heme)
ABX PENTRA Magnesium RTU
Magnesium Class II §862.1495 : Magnesium Test System JGJ ; photometric method, magnesium
ABX PENTRA Phosphorus CP
Phosphorus Class II &862.1580 : Phosphorus (inorganic) Test System CEO : phosphomolybdate (colorimetric), inorganic phosphorus
ABX PENTRA Urea CP
Urea Class II &862.1770 : Urea nitrogen Test System CDQ ; urease and glutamic dehydrogenase, urea nitrogen
ABX PENTRA Uric Acid CP
Uric Acid Class I §862.1775 : Uric acid Test System KNK ; acid, uric, uricase (colorimetric)
ABX PENTRA CO2 Control
CO2 Control Class I §862.1660 : Quality control material (assayed and unassayed) JJX ; single (specified) analyte controls (assayed and unassayed)
ABX PENTRA N Control (K052007)
N Control Class I §862.1660 : Quality control material (assayed and unassayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed and Unassayed)
2
| Trade/Proprietary Name: | |
|---|---|
| Common or Usual Name: | |
| Device Class | |
| Classification Name: | |
| Product Code: | |
Calibrators :
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
Common or Usual Name:
Classification Name:
Device Class
Product Code:
ABX PENTRA P Control (K052007)
P Control Class I §862.1660 : Quality control material (assayed and unassayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed and Unassayed)
ABX PENTRA Multical (K052007)
Multical Class II $862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture
Trade/Proprietary Name: ABX PENTRA CO2 Cal
CO2 Calibrator Class II 8862.1150 : Calibrator JIT ; calibrator, secondary
Substantial Equivalence:
The data and information supplied in this submission demonstrates substantial equivalence to their respective predicate devices :
| Submission device | Substantially equivalent
predicate device |
|--------------------------|----------------------------------------------|
| ABX PENTRA ALP CP | K801242 |
| ABX PENTRA Calcium CP | K883453 |
| ABX PENTRA CO2 RTU | K031879 |
| ABX PENTRA Creatinine CP | K941837 |
| ABX PENTRA Iron CP | K864819 |
| ABX PENTRA Magnesium RTU | K901758 |
| ABX PENTRA Phosphorus CP | K883962 |
| ABX PENTRA Urea CP | K954000 |
| ABX PENTRA Uric Acid CP | K922762 |
| ABX PENTRA CO2 Cal | K031879 |
| ABX PENTRA CO2 Control | K891475 |
3
Description:
All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX PENTRA 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module).
All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters
Intended Use :
All reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of their respective analytes (ALP - Alkaline Phosphatase, Calcium, C02, Creatinine, Iron, Magnesium, Phosphorus, Urea / Blood Urea Nitrogen, Uric Acid) using human serum and plasma.
The controls and calibrators are intended for use in association with the above reagents.
| Discussion of Performance Data: | |
|---|---|
| --------------------------------- | -- |
| ABX PENTRA ALP CP : | |
|---|---|
| Sample type | Serum & plasma |
| Detection limit | 6 U/l |
| Accuracy and Precision | CV Total Trade/Device Name: General Chemistries on ABX PENTRA 400 Clinical Chemistry Analyzer ABX PENTRA CO2 Cal ABX PENTRA CO2 Control Regulation Number: 21 CFR$ 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system |
Regulatory Class: Class II Product Code: CJE, CIC, KHS, CGX, JIY, JGJ, CEO, CDQ, KNK, JJX, JJY, JIX, JJT Dated: June 28, 2006 Received: June 30, 2006
JUL 2 1 2006
Dear Mr. Lawton:
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 (sec 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 vour 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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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) 276-0484. 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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto G.
Alberto Gutierrez, Ph.D Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
11
510(k) Number (if known):
Device Name: General Chemistries on ABX PENTRA 400 Clinical Chemistry Analyzer
Indications For Use:
General Chemistries reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.
ABX PENTRA ALP CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-Nitrophenylphosphate. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
ABX PENTRA Calcium CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of calcium in human serum and plasma based on a photometric test using orthocresolphtalein complexone. 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).
ABX PENTRA CO2 RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of carbon dioxide in human serum and plasma based on an enzymatic test using phosphoenolpyruvate (PEP), phosphorenolpyruvate carboxylase (PEPC) and an analog of NADH. Bicarbonate/carbon measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Page 1 of Office of In Vitro Diagnostic Device Junimation and Safety
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510(k) Number (if known): کرک(کی) کا کا
Device Name: General Chemistries on ABX PENTRA 400 Clinical Chemistry Analyzer
Indications For Use:
ABX PENTRA Creatinine CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of creatinine in human serum and plasma based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
ABX PENTRA Iron CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of iron (non-heme) in human serum and plasma based on a photometric test (Ferene method). Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and hemochromatosis.
ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. "Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of of An Vitko Diagnostic Diagnostic Devices (OIVD)
Office of In Vitro Diagnostic Devia
Evatud Saferv
KUL 0705
Page 2 of 5
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510(k) Number (if known):
Device Name: General Chemistries on ABX PENTRA 400 Clinical Chemistry Analyzer
Indications For Use:
ABX PENTRA Phosphorus CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of phosphorus in human serum and plasma based on a UV method using phosphomolybdate. Measurement of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
ABX PENTRA Urea CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of urea nitrogen (an end-product of nitrogen metabolism) in human serum and plasma based on an enzymatic UV test using urease and glutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
ABX PENTRA Uric Acid CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of uric acid in human serum and plasma based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |
|---|---|
| ------------------------------------------------------------------- | -- |
DIVISION SIGN-OFF
Page 3 of _
Office of In Viter Disgnostic Device Evaluation and Safety
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510(k) Number (if known): ΚΟύ Ολυ Συν
Device Name: ABX PENTRA CO2 Cal
Indications For Use:
The ABX PENTRA CO2 Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA CO2 RTU method on Horiba ABX clinical chemistry analyzers as specified on the vial.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |
|---|---|
| Office of In V. Diagnostic Device Evaluation and Safety | Page 4 of 5 |
| KOLCZUJ |
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510(k) Number (if known):
Device Name: ABX PENTRA CO2 Control
Indications For Use:
The ABX PENTRA CO₂ Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CO2 RTU method as specified in the enclosed annex.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
| Division Sign-Off | |
|---|---|
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| Page 1 of | 5 |
| 510(k) | K060205 |