(144 days)
R905027, K033501
No
The summary describes a standard benchtop clinical chemistry analyzer performing automated analytical procedures based on established chemical and electrochemical principles, with no mention of AI or ML.
No
This device is a clinical chemistry analyzer used for in vitro diagnostic testing to measure analytes in patient samples. It provides diagnostic information but does not directly treat or prevent a disease, which is characteristic of therapeutic devices.
Yes
The device measures glucose, sodium, chloride, and potassium, which are used in the diagnosis and treatment of various medical conditions, including carbohydrate metabolism disorders and electrolyte imbalances.
No
The device description clearly states it is a "benchtop clinical chemistry analyzer" that performs physical actions like pipetting, mixing, heating, and measuring color intensity using absorbance and ion selective electrodes. This indicates it is a hardware device with integrated software, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "quantitative in vitro determination of glucose in serum and plasma" and "quantitative determination of Sodium, Chloride, and Potassium by potentiometry using ion selective electrode". These are measurements performed on biological samples in vitro (outside the body) to provide information for diagnosis and treatment.
- Device Description: The description details a "benchtop clinical chemistry analyzer" that performs various analytical procedures on samples.
- Performance Studies: The document describes performance studies conducted on biological samples (serum, plasma, urine) to evaluate the device's ability to measure specific analytes.
- Predicate Devices: The listed predicate devices (Roche Cobas Mira Plus, Roche Ton Sector of Second Selective Electrode, Cobas Reagent for Glucose Rapid, Roche Precinorm U, Roche Precipath U) are all known IVD devices used for clinical chemistry analysis.
The core function of the ABX PENTRA 400, as described, is to analyze biological samples to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ABX PENTRA 400 is a discrete photometric benchtop chemistry analyzer for clinical use.
The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity.
The device is intended for use in conjunction with certain materials to measure, control and calibrate a variety of analytes.
The option of an ISE (Ion Selective Electrode) module is intended for the quantitative determination of Sodium, Chloride, Potassium by potentiometry using ion selective electrode.
ABX PENTRA Glucose HK CP, Glucose PAP CP reagents with associated calibrators and controls are for quantitative in vitro determination of glucose in serum and plasma using glucose hexokinase and glucose oxidase methods by colorimetry. Glucose measurements are used in diagnosis and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The option of an I.S.E. (Ion Selective Electrode) module is intended for the quantiative determination of Sodium, Chloride, and Potassium by potentiometry using ion selective electrode with associated calibrators and controls. Measurement of these electrolytes are used in diagnosis and treatment diseases involving electrolyte imbalance.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers as specified in the enclosed annex.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
Product codes (comma separated list FDA assigned to the subject device)
JJE, JGS, CEM, CGZ, JJP, CFR, CGA, JIX, JJY
Device Description
The ABX PENTRA 400 is a benchtop clinical chemistry analyzer using two measuring principals absorbance and ion selective electrodes.
The instrument may be summarized as follows :
- Multi-parametric (up to 52 simultaneous tests + 3 ISE tests)
- Patient per patient
- On routine or Stat
- 150 to 300 tests / hour (in single or bi-reaction mode) (analytical cycle of 12seconds)
- random access working on primary tubes or sample cups
- ABX PENTRA reagent cassettes are compact and ready-to-use.
- ABX PENTRA readers are used to identify newly loaded reagent cassettes and samples for patient identification
The ABX PENTRA 400 offers both Closed and Open channels for a multitude of clinical tests (Enzymes, Substrates, Electrolytes, Specific Proteins, DOA, TDM, plasma protein, hemostasis, optional ISE module).
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)
ABX PENTRA Glucose HK CP:
- Sample type: Serum & plasma
- Detection limit: 1.98 mg/dl
- Accuracy and Precision: CV Total
§ 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.
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DEC 16 2005
Premarket Notification [510(k)] Summary
This summary of 510(k) safety and effectiveness information is being submitted in I m3 summary of 510(tr) sales) and 1990 and 21 CFR 807.92
The assigned 510(k) number is : K052007
Horiba ABX Company: Parc Euromédecine Rue du Caducée – BP 7290 34184 Montpellier cedex 4 FRANCE + (33) 4 67 14 73 20 Telephone: + (33) 4 67 14 15 17 Fax:
Contact Person: Tim Lawton (tlawton@fr.abx.fr)
Date Prepared: 16th November 2005
Device Name:
Classification Name:
Product Code:
| Trade/Proprietary Name:
Common or Usual Name:
Device Class
Classification Name: | ABX PENTRA 400 Clinical Chemistry Analyzer
Clinical Chemistry analyzer
Class I : General Controls : Exempt from premarket.
§862.2160 : Discrete photometric chemistry analyzer for
clinical use |
|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code: | JJE |
| Trade/Proprietary Name:
Common or Usual Name:
Device Class
Classification Name:
Product Code: | I.S.E Module (Optional)
Ion Selective Electrode Option
Class I : General Controls : Exempt from premarket.
§862.2160 : Discrete photometric chemistry analyzer for
clinical use
JJE |
| Electrodes :
Trade/Proprietary Name:
Common or Usual Name:
Device Class | ABX PENTRA Sodium-E
Sodium Electrode
Class II |
Class II §862.1665 : Sodium Test System JGS : electrode, ion specific, sodium
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: for a specific medical use Product Code:
Reagents :
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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:
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 Chloride -E
Chloride Electrode Class II $862.1170 : Chloride Test System CGZ : electrode, ion-specific, chloride
ABX PENTRA Potassium -E
Potassium Electrode Class II $862.1600 : Potassium Test System CEM : electrode, ion specific, potassium
ABX PENTRA Reference -E
Reference Electrode Class I : 510(k) exempt 5862.2050 : General purpose laboratory equipment labeled or promoted
JJP : electrode, ion specific (non-specified)
ABX PENTRA Glucose HK CP
Glucose HK Class II $862.1345 : Glucose Test System CFR ; Hexokinase, Glucose
ABX PENTRA Glucose PAP CP
Glucose PAP Class II §862.1345 : Glucose Test System CGA ; Glucose Oxidase, Glucose
ABX PENTRA Multical
Multical Class II 8862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture
ABX PENTRA Standard 1
Standard 1 Class II 8862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture
ABX PENTRA Standard 2
Standard 2 Class II $862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture
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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:
Cleaning solutions :
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:
ABX PENTRA Reference
Reference Class II $862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture
ABX PENTRA N Control
N Control Class I §862.1660 : Quality control material (assayed and unassayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed and Unassayed)
ABX PENTRA P Control
P Control Class ! $862.1660 : Quality control material (assayed and unassayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed and Unassayed)
ABX PENTRA Clean-Chem CP
Clean-Chem Class I : Exempt from Premarket Notification Not available Not available
ABX PENTRA Clean-Chem 99 CP
Clean-Chem 99 Class I : exempt from Premarket Not available Not available
ABX PENTRA Deproteinizer CP
Deproteinizer Class 1 : Exempt from Premarket Not available Not available
ABX PENTRA Etching CP
Etching Class I : Exempt from Premarket Not available Not available
Substantial Equivalence:
The ABX PENTRA 400 is a new device developed by HoribaABX. It has been demonstrated that the ABX PENTRA 400 can be considered substantially equivalent to the predicate device Roche Cobas Mira Plus (K920402).
3
The optional ISE module has been similarly demonstrated as being substantially The optional ISE moductias been shimally done elective Electrode. Whilst the ABX PENTRA equivalent to R905027, the Rooms Ton Sector of Second PAP CP have been demonstrated Glucose HK CF, and ADX FENTRY Gracoss Preagent for Glucose Rapid (K801297).
substantially equivalent to K801297; the Cobas Reagent DV PENTERA P Courted how substaniany equivalent to K601297, the Coose - 110 Control and ABX PENTRA P Control have a ADA FENTRA Munical, ADA PER PER EF eing substantially equivalent to K033501, Roche been respectively demonstated as being blockers, Roche Precinorm U and Roche Precipath U.
Description:
Description.
The ABX PENTRA 400 is a benchtop clinical chemistry analyzer using two measuring principals absorbance and ion selective electrodes.
The instrument may be summarized as follows :
- Multi-parametric (up to 52 simultaneous tests + 3 ISE tests) ।
- Patient per patient -
- On routine or Stat -
- On routine of Stat
150 to 300 tests / hour (in single or bi-reaction mode) (analytical cycle of 12seconds) - - random access working on primary tubes or sample cups -
- ABX PENTRA reagent cassettes are compact and ready-to-use. -
- ADATEATIC Freaders are used to identify newly loaded reagent cassettes and samples for patient identification
The ABX PENTRA 400 offers both Closed and Open channels for a multitude of Phe ADA I ENTERS 400 Offers COLL, TDM, plasma protein, hemostasis, optional ISE module).
Intended Use :
The ABX PENTRA 400 is a discrete photometric benchtop chemistry analyzer for clinical use.
The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity.
The device is intended for use in conjunction with certain materials to measure, control and calibrate a variety of analytes.
The option of an ISE (Ion Selective Electrode) module is intended for the quantitative determination of Sodium, Chloride, Potassium by potentiometry using ion selective electrode.
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Discussion of Performance Data:
| ABX PENTRA Glucose HK CP: | |
|---|---|
| Sample type | Serum & plasma |
| Detection limit | 1.98 mg/dl |
| Accuracy and Precision | CV Total |