(144 days)
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 a variety of analytes. 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 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 quantitative determination of Sodium, Chloride, and Potassium by potentiometry using ion selective electrode with associated calibrators and controls. Measurement of these elements are used in diagnosis and treatment diseases involving electrolyte imbalance.
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, Automatic 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 applications (clinical chemistry, TDM, plasma protein, hemostasis, optional ISE module).
The provided text describes the ABX PENTRA 400 Clinical Chemistry Analyzer and various associated components. The study focuses on demonstrating substantial equivalence to predicate devices, rather than establishing primary performance criteria for an AI device. Therefore, several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness, standalone performance, ground truth for training set) are not applicable or cannot be extracted from this type of regulatory submission for a clinical chemistry analyzer.
However, I can provide the acceptance criteria and reported device performance for the analytes tested, as well as some information about the study design that can be inferred.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides performance data for several analytes (Glucose HK CP, Glucose PAP CP, Chloride-E, Potassium-E, Sodium-E). The "acceptance criteria" are implicitly met by the reported performance figures demonstrating substantial equivalence to predicate devices. For a clinical chemistry analyzer, key performance indicators include accuracy, precision (measured as CV Total), linearity/measuring range, and correlation with existing methods.
| Analyte (reagent/electrode) | Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|---|
| ABX PENTRA Glucose HK CP | Detection limit | Not explicitly stated, but within acceptable clinical range | 1.98 mg/dl |
| Accuracy and Precision | CV Total within acceptable limits | CV Total < 2.03% | |
| Measuring range | Clinically relevant range | 1.98 mg/dl – 900 mg/dl (Automatic post-dilution: 2700 mg/dl) | |
| Correlation (n=103) | High correlation (r²) to predicate/reference method | Y = 0.93 x + 2.70 with r² = 0.9958 | |
| Calibration stability | Clinically acceptable duration | 14 days | |
| Reagent stability | Clinically acceptable duration | on-board: 55 days | |
| ABX PENTRA Glucose PAP CP | Detection limit | Not explicitly stated, but within acceptable clinical range | 1.80 mg/dl |
| Accuracy and Precision | CV Total within acceptable limits | CV Total < 1.44 % | |
| Measuring range | Clinically relevant range | 1.80 mg/dl - 432 mg/dl (Automatic post-dilution: 1296 mg/dl) | |
| Correlation (n=103) | High correlation (r²) to predicate/reference method | Y = 0.98 x + 0.72 with r² = 0.9974 | |
| Calibration stability | Clinically acceptable duration | 11 days | |
| Reagent stability | Clinically acceptable duration | on-board: 83 days | |
| ABX PENTRA Chloride-E | Accuracy and Precision | CV Total within acceptable limits | CV Total < 1.21 % |
| Linearity & Measuring range | Clinically relevant range | Plasma/Serum: 85 - 200 mmol/l; Urine: 70 - 300 mmol/l | |
| Correlation (n=152 Serum/Plasma, n=103 Urine) | High correlation (r²) to predicate/reference method | Serum/Plasma: Y = 1.09 x - 10.60 with r² = 0.9651; Urine: Y = 0.99 x + 2.64 with r² = 0.9730 | |
| ABX PENTRA Potassium-E | Accuracy and Precision | CV Total within acceptable limits | CV Total < 1.56 % |
| Linearity & Measuring range | Clinically relevant range | Plasma/Serum: 1.4 - 10 mmol/l; Urine: 2 - 150 mmol/l | |
| Correlation (n=100 Serum, n=100 Plasma, n=103 Urine) | High correlation (r²) to predicate/reference method | Serum: Y = 1.00 x + 0.00 with r² = 0.9988; Plasma: Y = 1.00 x + 0.00 with r² = 0.9977; Urine: Y = 1.03 x - 0.72 with r² = 0.9753 | |
| ABX PENTRA Sodium – E | Accuracy and Precision | CV Total within acceptable limits | CV Total < 0.92 % |
| Linearity & Measuring range | Clinically relevant range | Plasma/Serum: 110 – 200 mmol/l; Urine: 80 – 300 mmol/l | |
| Correlation (n=100 Serum, n=100 Plasma, n=103 Urine) | High correlation (r²) to predicate/reference method | Serum: Y = 0.98 x + 2.64 with r² = 0.9991; Plasma: Y = 0.97 x + 4.77 with r² = 0.9960; Urine: Y = 1.00 x + 1.00 with r² = 0.9851 |
2. Sample sizes used for the test set and the data provenance:
- Glucose HK CP & Glucose PAP CP: n=103 for correlation studies (presumably patient samples). The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but given Horiba ABX is based in France, the studies were likely conducted in France or Europe.
- Chloride-E: n=152 for Serum/Plasma correlation, n=103 for Urine correlation.
- Potassium-E: n=100 for Serum correlation, n=100 for Plasma correlation, n=103 for Urine correlation.
- Sodium-E: n=100 for Serum correlation, n=100 for Plasma correlation, n=103 for Urine correlation.
- Data Provenance: Not explicitly stated, but given the company location, likely European/French data. The studies are clinical performance studies conducted to demonstrate equivalence, which typically involves prospective collection of samples or retrospective use of stored clinical samples. The document refers to "Clinical testing" which implies prospective data collection, but it's not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable for a clinical chemistry analyzer. "Ground truth" for these devices typically refers to established reference methods or predicate device measurements, not expert human interpretation.
4. Adjudication method for the test set:
Not applicable. As described above, this is not an interpretive AI device; it's a device measuring chemical analytes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the studies presented are "standalone" performance studies for the clinical chemistry analyzer and its components. The device measures analytes automatically; there is no human-in-the-loop performance analysis in this context beyond the technician operating the instrument and interpreting the numerical results. The performance metrics (accuracy, precision, linearity, correlation) represent the device's intrinsic function.
7. The type of ground truth used:
The "ground truth" in these studies is the measurement obtained from:
- Predicate devices: The performance data is presented in correlation studies, comparing the ABX PENTRA 400 (and its reagents/electrodes) results (Y) against another method (X), likely the predicate device or a recognized reference method. For example, "Correlation ... Y = 0.93 x + 2.70 with a correlation coefficient r² = 0.9958" implies a comparison against another method (x).
- Reference materials/known concentrations: Accuracy, precision, detection limit, linearity, and measuring range are typically established using reference materials with known concentrations and repeated measurements.
8. The sample size for the training set:
Not applicable. This device is a traditional clinical chemistry analyzer, not an AI/machine learning model that requires a distinct "training set." Its calibration involves specific calibrator solutions (e.g., ABX Pentra Multical, Standard 1, Standard 2, Reference), not a "training set" in the AI sense.
9. How the ground truth for the training set was established:
Not applicable, as there isn't a "training set" in the AI sense for this type of device. The calibration and performance verification are based on established laboratory practices, using commercially available calibrators and controls that have their own defined values.
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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 ClassClassification Name: | ABX PENTRA 400 Clinical Chemistry AnalyzerClinical Chemistry analyzerClass I : General Controls : Exempt from premarket.§862.2160 : Discrete photometric chemistry analyzer forclinical use |
|---|---|
| Product Code: | JJE |
| Trade/Proprietary Name:Common or Usual Name:Device ClassClassification Name:Product Code: | I.S.E Module (Optional)Ion Selective Electrode OptionClass I : General Controls : Exempt from premarket.§862.2160 : Discrete photometric chemistry analyzer forclinical useJJE |
| Electrodes :Trade/Proprietary Name:Common or Usual Name:Device Class | ABX PENTRA Sodium-ESodium ElectrodeClass II |
Class II §862.1665 : Sodium Test System JGS : electrode, ion specific, sodium
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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 :
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:
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).
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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.
{4}------------------------------------------------
Discussion of Performance Data:
| ABX PENTRA Glucose HK CP: | |
|---|---|
| Sample type | Serum & plasma |
| Detection limit | 1.98 mg/dl |
| Accuracy and Precision | CV Total < 2.03% |
| Measuring range | 1.98 mg/dl – 900 mg/dlAutomatic post-dilution : 2700 mg/dl |
| Correlation (n=103) | Y = 0.93 x + 2.70 with a correlation coefficient r² = 0.9958. |
| Calibration stability | 14 days |
| Reagent stability | on-board stability (refrigerated area): 55 days |
| Calibrator | ABX Pentra Multical |
| Controls | ABX Pentra N ControlABX Pentra P Control |
| ABX PENTRA Glucose PAP CP: | |
|---|---|
| Sample type | Serum & plasma |
| Detection limit | 1.80 mg/dl |
| Accuracy and Precision | CV Total < 1.44 % |
| Measuring range | 1.80 mg/dl - 432 mg/dlWith automatic post-dilution : 1296 mg/dl |
| Correlation (n=103) | Y = 0.98 x + 0.72 with a correlation coefficient r2 = 0.9974. |
| Calibration stability | 11 days |
| Reagent stability | on-board stability (refrigerated area): 83 days |
| Calibrator | ABX Pentra Multical |
| Controls | ABX Pentra N ControlABX Pentra P Control |
. .
{5}------------------------------------------------
| ABX PENTRA Chloride- E : | |
|---|---|
| Sample type | Serum, plasma & urine |
| Accuracy and Precision | CV Total < 1.21 % |
| Linearity & Measuring range | Plasma / Serum : 85 - 200 mmol/lUrine : 70 - 300 mmol/l |
| CorrelationSerum / Plasma (n=152)Urine (n=103) | $Y = 1.09 x - 10.60 with a correlation coefficient r² = 0.9651.$$Y = 0.99 x + 2.64 with a correlation coefficient r² = 0.9730.$ |
| Calibrators | ABX Pentra Standard 1ABX Pentra Standard 2ABX Pentra Reference |
| Controls | ABX Pentra N ControlABX Pentra P Control |
| ABX PENTRA Potassium- E : | |
|---|---|
| Sample type | Serum, plasma & urine |
| Accuracy and Precision | CV Total < 1.56 % |
| Linearity & Measuring range | Plasma / Serum : 1.4 - 10 mmol/l |
| Urine : 2 - 150 mmol/l | |
| CorrelationSerum (n=100)Plasma (n=100)Urine (n=103) | Y = 1.00 x + 0.00 with a correlation coefficient r2 = $0.9988$ .Y = 1.00 x + 0.00 with a correlation coefficient r2 = $0.9977$ .Y = 1.03 x - 0.72 with a correlation coefficient r2 = $0.9753$ . |
| Calibrators | ABX Pentra Standard 1 |
| ABX Pentra Standard 2 | |
| ABX Pentra Reference | |
| Controls | ABX Pentra N ControlABX Pentra P Control |
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| ABX PENTRA Sodium – E : | |
|---|---|
| Sample type | Serum, plasma & urine |
| Accuracy and Precision | CV Total < 0.92 % |
| Linearity & Measuring range | Plasma / Serum : 110 – 200 mmol/lUrine : 80 – 300 mmol/l |
| CorrelationSerum (n=100)Plasma (n=100)Urine (n=103) | Y = 0.98 x + 2.64 with a correlation coefficient r² = 0.9991.Y = 0.97 x + 4.77 with a correlation coefficient r² = 0.9960.Y = 1.00 x + 1.00 with a correlation coefficient r² = 0.9851. |
| Calibrators | ABX Pentra Standard 1ABX Pentra Standard 2ABX Pentra Reference |
| Controls | ABX Pentra N ControlABX Pentra P Control |
Conclusions for non clinical and clinical tests :
Conclusions for 1882 studies that the safety and effectiveness of the devices are not compromised.
The ABX PENTRA 400 (Option ISE) meets the :
- ADA TENTICA 400 (Option 102) incents for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
- EN 61326 : standard for Electrical equipment for measurement, control and laboratory use EMC requirements
- UL 3101 -- 1 / CSA -- C22.2 No. 1010-1 : Safety Requirements for Electrical Equipement for measurement, control, and laboratory use, Part 1 : General Requirements
Clinical testing met all acceptance criteria, and data demonstrates that the devices are substantially equivalent to their predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three tail feathers, representing the three branches of government. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 16 2005
Mr. Tim Lawton Regulatory Affairs Manager Horiba ABX Parc Euromèdecine Rue du Caducèe – BP 7290 34184 Montpellier cedex 4 France
K052007 Re:
R052007
Trade/Device Name: ABX PENTRA 400 Clinical Chemistry Analyzers ABX PENTRA 400 Calibrators and Controls Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR, JGS, CEM, CGZ, JIX, JJY, JJE Dated: November 16, 2005 Received: November 21, 2005
Dear Mr. Lawton:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) (c regars) the enactment date of the Medical Device Amendments, or to conninered pror co rize) 2017-11-17, 11 accordance with the provisions of the Federal Food, Drug, de MCS mat have been recuire approval of a premarket approval application (PMA). and Cosmetic Tree (1100) that the device, subject to the general controls provisions of the Act. The r ou may, attress provisions of the Act include requirements for annual registration, listing of general controls provincities, 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 n may 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 r lease of acressed that I Dr. mination that your device complies with other requirements of the Act that I Drival statutes and regulations administered by other Federal agencies. You must or any I odotar statuates and requirements, including, but not limited to: registration and listing (21 compty with7); 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) This letter will anow you to ough manieting of substantial equivalence of your device to a legally prematics notification: "The PDT Interlig stification 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, II you destions on the promotion and advertising of your device, please contact the Office of In of questions on the prometical ation and Safety at (240) 276-0484. Also, please note the V Into Diagnosuo Dorto Branding by reference to premarket notification" (21CFR Part 807.97). Tegulation chities, Triboranang of Streetion on your responsibilities under the Act from the I ou may other belief other generational 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. A.
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
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510(k) Number (if known): X 5 5 2 0 0 7
Device Name: _ABX PENTRA 400 Clinical Chemistry Analyzer Option : I.S.E. module
Indications For Use:
The ABX PENTRA 400 is a discrete photometric benchtop chemistry analyzer for clinical use.
clinical use.
The device is intended to duplicate manual analytical procedures by performing various The device is intention to daptions the suring color intensity.
The device is intended for use in conjunction with certain materials to measure a variety of analytes.
ABX PENTRA Glucose HK CP, Glucose PAP CP reagents with associated calibrators ABA PENTRA Glucose TH OF , Slaose FAN OF , Slaoses . An Selumination of glucose in serium and controls are for quantitative in vi... 8 alaghes methods by colorimetry.
and plasma using glucose hexokinase and glucose oxidase methods by coloriments and plasma using glucoso noxoninates and treatment of carbohydrate Glucose measuremonto are acceliabetes 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 The option of Sodium, Chloride, and Potassium by potentiometry using ion selective delemmination of Obduin, Onliner, and For, valibrators and controls. Measurement of electrode with associated forement are used in diagnosis and treatment diseases involving electrolyte imbalance.
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)
Albert Schertz
Division Sign-Off
Office of In Vitro Dlagr Device Evaluation and
510(k) K052007
Page 1 of
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: ABX PENTRA Multical
Indications For Use:
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.
Prescription Use X (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)
signature
Circ of In Viro Diagnostic Device . Frion End Salocy
KOSZOOD
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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510(k) Number (if known): K052007
Device Name: ABX PENTRA N Control
Indications For Use:
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.
Prescription Use X (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)
signature
- rf In Vitro Diagnostic Device
Page 1 of _
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011
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510(k) Number (if known):________________ )
Device Name: ABX PENTRA P Control
Indications For Use:
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.
Prescription Use X (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)
signature
- s of In Vitro Diagnostic Device for, and Sufery
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Kcs2007
§ 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.