(267 days)
ABX Pentra Calcium AS CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on a colourimetric method, using the ABX Pentra 400 Clinical Chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
All the reagent, controls and calibrator 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 Calcium AS CP is an in vitro diagnostic assay for the quantitative in vitro determination of calcium in human serum, plasma and urine based on colourimetric method. It is composed of a monoreagent cassette (79 mL). The reagent is chemical solution with additives.
The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer.
This calibrator is provided in ten vials of 3 ml.
The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.
Here's a summary of the acceptance criteria and study details for the ABX PENTRA CALCIUM AS CP device and its associated controls and calibrators, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied/General Industry Practice for IVDs) | Reported Device Performance (ABX Pentra Calcium AS CP) |
|---|---|---|
| Detection Limit | (Not explicitly stated, but lower is better) | Serum/Plasma: 0.28 mg/dl; Urine: 0.23 mg/dl |
| Limit of Quantitation | (Not explicitly stated, but lower is better) | Serum/Plasma: 1.54 mg/dl; Urine: 0.64 mg/dl |
| Repeatability (CV%) | (Typically low CV% for good precision) | Serum/Plasma: • Control 1: 0.49% • Control 2: 0.37% • Specimen 1: 0.71% • Specimen 2: 0.40% • Specimen 3: 0.43% Urine: • Control 1: 0.62% • Control 2: 0.76% • Specimen 1: 0.46% • Specimen 2: 0.56% • Specimen 3: 0.37% |
| Reproducibility (CV%) | (Typically low CV% implying precision over time) | Serum/Plasma: • Control 1: 1.44% • Control 2: 1.49% • Specimen 1: 1.56% • Specimen 2: 1.54% • Specimen 3: 1.54% Urine: • Control 1: 1.45% • Control 2: 1.50% • Specimen 1: 1.57% • Specimen 2: 1.57% • Specimen 3: 1.56% |
| Measuring Range (Linearity) | (Demonstrate linearity within clinical range) | Serum/Plasma: 4.0 mg/dl - 18.05 mg/dl (up to 54.15 mg/dl with post-dilution); Urine: 0.64 mg/dl - 18.05 mg/dl (up to 54.15 mg/dl with post-dilution) |
| Method Comparison (Correlation with Reference) | (High correlation, ideally slope ≈ 1, intercept ≈ 0) | Serum/Plasma: Y = 1.00 x + 0.04 (mg/dl), r² = 0.9903 Urine: Y = 0.98 x -0.03 (mg/dl), r² = 0.993 |
| Matrix Comparison | (High correlation between serum and plasma) | Y = 1.006x - 0.0022, r² = 0.996 (for serum vs. lithium plasma) |
| Calibration Stability | (Period for which calibration holds) | 10 days (for serum/plasma and urine) |
| Reagent Stability | (Shelf-life and on-board stability) | Closed stability: 24 months at 2-8°C; On-board stability: 60 days at 2-8°C |
2. Sample Size Used for the Test Set and Data Provenance
- Detection Limit & Limit of Quantitation: Not specified for individual samples, but determined according to CLSI (NCCLS), EP17-A protocol.
- Repeatability (within-run precision):
- 3 specimens (low, medium, high concentration)
- 2 controls
- Each tested 20 times.
- Data provenance: Not explicitly stated, but likely from laboratory testing conducted by Horiba ABX SAS, France. Retrospective/Prospective is not specified.
- Reproducibility (total precision):
- 3 specimens (low, medium, high levels)
- 2 controls
- Each tested in duplicate for 20 days (2 series per day).
- Data provenance: Not explicitly stated, but likely from laboratory testing conducted by Horiba ABX SAS, France. Retrospective/Prospective is not specified.
- Method Comparison:
- Serum/Plasma: n = 145 patient samples
- Urine: n = 143 patient samples
- Data Provenance: Not explicitly stated beyond "patient samples," but implied to be from a clinical setting, likely in France given the company's location. Retrospective/Prospective is not fully specified, but patient samples are used to compare against a "commercial reagent taken as reference," suggesting a retrospective collection of samples for comparison.
- Matrix Comparison:
- n = 32 paired serum and lithium plasma samples (3 samples were altered)
- Data Provenance: Not explicitly stated beyond "samples," but implied to be from a clinical setting, likely in France. Retrospective/Prospective is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to in vitro diagnostic (IVD) assays for quantitative chemical measurements. The "ground truth" for these studies is typically established by measurements from a well-characterized reference method or a predicate device, rather than expert consensus on images or clinical assessments. The studies performed here compare the device to a "commercial reagent taken as reference" (predicate device K061575) and uses established laboratory protocols (CLSI, Valtec).
4. Adjudication Method for the Test Set
Not applicable. The "ground truth" is derived from quantitative measurements by reference methods, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret images, sometimes with AI assistance. This document describes a clinical chemistry analyzer and reagents, which do not involve human interpretation of images in the same way.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies described are standalone performance evaluations of the assay system (reagent and instrument). The performance metrics (detection limits, precision, linearity, method comparison, stability) reflect the algorithm's and the physical assay's performance without direct human interpretation influencing the measurement results. The human input is in setting up the system, running controls, and interpreting the numerical output, but the analytical measurement itself is automated.
7. Type of Ground Truth Used
- Reference Method/Predicate Device Comparison: For the method comparison study, the "ground truth" was established by measurements from a "commercial reagent taken as reference" (Olympus Calcium Arsenazo reagent, K061575).
- CLSI/NCCLS Protocols: Other performance parameters (detection limit, quantitation limit, precision, linearity) were evaluated against established CLSI/NCCLS and Valtec protocols, which define acceptable measurement performance characteristics. These protocols inherently define the "truth" in terms of statistical and analytical performance.
8. Sample Size for the Training Set
Not applicable. This device is a quantitative in vitro diagnostic reagent and assay system, not an AI/machine learning model that requires a training set in the conventional sense. The development of the reagents and assay parameters is based on chemical and analytical principles, and the performance is validated through the studies listed.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of IVD device.
{0}------------------------------------------------
Premarket Notification [510(k)] Summary
JUL 0 3 2013
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
The assigned 510(k) number is : K123171
Company: Horiba ABX SAS Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE Telephone: + (33) 4 67 14 18 43 + (33) 4 67 14 15 17 Fax:
Contact Person: Caroline Ferrer (caroline.ferrer@horiba.com)
Date Prepared: 02nd July, 2013
A. Device Names:
The following reagent, controls & calibrators are for use in conjunction with the ABX PENTRA 400 instrument, cleared to market under K052007.
REAGENTS :
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA CALCIUM AS CP Calcium Arsenazo
Class II §862.1145 : Calcium test system CJY: Azo Dye, Calcium
CALIBRATORS:
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:
ABX PENTRA Multical (Already cleared to market under K052007) Multical · Class II
§862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture
ABX PENTRA N Control (Already cleared to market under K052007) N Control Class I
§862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed)
{1}------------------------------------------------
| Trade/Proprietary Name: | ABX PENTRA P Control (Already cleared to market under K052007) |
|---|---|
| Common or Usual Name: | P Control |
| Device Class | Class I |
| Classification Name: | §862.1660 : Quality control material (assayed) |
| Product Code: | JJY ; Multi-Analyte Controls, All Kinds (assayed) |
| Trade/Proprietary Name: | ABX PENTRA Urine Control L/H (Already cleared to market) |
| under K070249) | |
| Common or Usual Name: | Urine control |
Urine Class I §862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed)
B. Substantial Equivalence:
Device Class
Product Code:
Classification Name:
The data and information supplied in this submission demonstrates substantial equivalence to their respective predicate devices:
| Submission device | Substantially equivalentPredicate device |
|---|---|
| ABX Pentra Calcium AS CP | K061575 |
| ABX Pentra Multical | K052007 |
| ABX Pentra N Control | K052007 |
| ABX Pentra P Control | K052007 |
| ABX Pentra Urine Control L/H | K070249 |
Comparison of new device (ABX Pentra Calcium AS CP ) with the predicate device l . ، (Olympus Calcium Arsenazo reagent):
- Similarities : -
| Predicate device (K061575): | New Device : | |
|---|---|---|
| Device Name | Olympus Calcium Arsenazoreagent | ABX Pentra Calcium AS CP |
| Indications for use | Olympus Calcium Arsenazoreagent is a diagnostic reagent forquantitative in vitro determinationof calcium in human serum, plasmaand urine by colorimetry.Measurement of calcium is used inthe diagnosis and treatment ofparathyroid disease, a variety ofbone diseases, chronic renal diseaseand tetany (intermittent muscularcontractions or spasms). | Identical |
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| Analytes | Calcium | Identical |
|---|---|---|
| Method | Calcium ions (Ca2+) react withArsenazo III (2,2'-[1,8-Dihydroxy-3,6-disulphonaphthylene-2,7-bisazo]- bisbenzenearsonic acid) toform an intense purple colouredcomplex. The absorbance of theCa-Arsenazo III complex ismeasured bichromatically at660/700 nm. The resulting increasein absorbance of the reactionmixture is directly proportional tothe calcium concentration in thesample. | Identical |
| Specimen | Serum, plasma and urine | Identical |
| Closed reagentstability | Until the expiration date printed onthe label when stored at 2-8°C | Identical |
| Format | Liquid | Identical |
Differences : -
.
| Predicate device (K061575): | Device : | |
|---|---|---|
| Device Name | Olympus Calcium Arsenazoreagent | ABX Pentra Calcium AS CP |
| Manufactured by | Olympus Corp /Beckman Coulter | HORIBA ABX SAS, France |
| Instrument | Clinical chemistry analyzer | ABX PENTRA 400 |
| Component reagentmatrices | Mono reagent bottle, ready to use.Final reactive ingredient: Arsenazo III | Mono reagent cassette, readyto use.Final reactive ingredient:Identical |
| Label | - | Horiba Medical specific label |
| Notice | Beckman Coulter specific notice | Horiba Medical specific notice |
| Packaging | Mono reagent bottleREAGENT: 4 x15 ml | Mono-reagent cassette :REAGENT : 1x79 ml |
| Controls | Commercially available qualitycontrol material (not included):Controls Cat. No.ODC0003 andODC0004 for serum/plasma.Biorad Liquichek Urine ChemistryControls Cat. No. 397 and 398 forurine. | Recommended quality controlmaterial (not included):ABX Pentra N Control andABX Pentra P Control forserum /plasma.ABX Pentra Urine ControlL/H for urine. |
| Calibrators | Commercially available calibrator(not included):System Calibrator Cat. No. 66300for serum/plasma application andUrine Calibrator Cat. No.ODC0025 for urine | Recommended calibrationmaterial (not included):ABX Pentra Multical |
| Open Reagentstability | Once open, reagent stored on boardthe instrument is stable for 90 days. | Once opened, the reagentcassette placed in theinstrument (refrigerated |
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:
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| stable for 60 days |
|---|
| -------------------- |
-
- Comparison of new device (ABX Pentra MULTICAL) with the predicate device (ABX Pentra MULTICAL already cleared to market under K052007):
The ABX Pentra MULTICAL was previously described and cleared by the FDA under K052007 and the following submissions K062737, K060205, K062180, K060854, K060434, K072115, K110137, K110530.
- Comparison of new device (ABX Pentra MULTICAL) with the predicate device (ABX Pentra MULTICAL already cleared to market under K052007):
However we have added it in this submission, as it is used in combination with a parameter. The only difference between the previously cleared calibrator and the ones included in this submission is the parameter calibrated submitted to the FDA.
| Predicate device (K052007): | Device : | |
|---|---|---|
| Device Name | ABX Pentra MULTICAL | ABX PentraMULTICAL |
| Manufactured by | Roche | Unchanged |
| Commercialized by | HORIBA ABX SAS, France | Unchanged |
| Instrument | ABX PENTRA 400 | Unchanged |
| Method : | Calibration of HORIBA Medical methods onclinical chemistry analyzers | Unchanged |
| Component reagentmatrices | -Vial (lyophilizate)-Human serum with chemical additives and tissueextracts of human and animal origin | Unchanged |
| Biological additives | ALT (GPT), AST (GOT), Albumin, Aldolase,Alkaline phosphatase, Amylase total, PancreaticAmylase, Cholesterol, Cholinesterase, CreatineKinase, Gamma-GT, GLDH, LD (LDH), Lipase,Acid phosphatase, Total proteins | Unchanged |
| Format | Lyophilizate (to reconstitute with distilled/deionisedwater - not provided) | Unchanged |
| Labels | Horiba Medical specific label | Unchanged |
| Notice | Horiba Medical specific notice | Unchanged |
| Packaging | Kit composed of :10 x bottle, each with lyophilizate for 3 mlcalibrator | Unchanged |
| Performance data :Calibration values | Determined using parameter-specificmethods (mentioned in the annex) under strictlystandardized conditions on HORIBA Medical | Unchanged |
Similarities : -
{4}------------------------------------------------
| analyzers using HORIBA Medical system reagentsand HORIBA Medical master calibratorThe calibration value specified is the medianof the values obtainedThe assigned values are indicated in theannex enclosed in the kitThe values are lot-specific. | ||
|---|---|---|
| Performance data :Closed stability | 24 months at 2-8°C | Unchanged |
| Performance data :Components** stabilityafter reconstitution of thecalibrator | At 15 to 25°C : 8 hoursAt 2 to 8°C: 2 daysAt -25°C to -15°C: 2 weeks (when frozen once)**Exceptions:Stability of Direct BilirubinAt 15 to 25°C: 3 hoursAt 2 to 8°C: 8 hoursAt -25°C to -15°C: 2 weeks (when frozen once)Stability of Total BilirubinAt 15 to 25°C: 6 hoursAt 2 to 8°C: 1 dayAt -25°C to -15°C: 2 weeks (when frozen once) | Unchanged |
·
Differences : -
:
:
.
י
.
| Device (K052007): | Device: | |
|---|---|---|
| Device Name | ABX Pentra MULTICAL | ABX PentraMULTICAL |
| Calibrated molecules | The exact calibrator values aregiven in the enclosed annex | Updated toinclude newapplicationvalues for newarsenazo calcium |
| Calibrated molecules: ALP, ALT,Amylase, AST, Creatine kinase, GGT,Lipase, Albumin, Direct Bilirubin, TotalBilirubin, Calcium, Cholesterol,Creatinine 120, Glucose HK, GlucosePAP, Iron, Lactic Acid, Magnesium,Phosphorus, Total Protein, Total protein100, Triglyverides, Urea/BUN, Uric acid,Enzymatic Creatinine, New ArsenazoCalcium | Applications cleared K060205CLIA K062180 K06318 K062737CLIA CLIA K060434 K060325K060325 K060205 K060854K072115 - K062007 K062007K060505 CLIA K060205K060205 K060434 K072115K060854 K060205 K060205K110137 K110530 | NewArsenazoCalciumApplication notcleared (in thissubmission) |
| Value sheet/Annex | Horiba Medical specific annex | New HoribaMedical specificannex |
.
:
{5}------------------------------------------------
- Comparison of new device (ABX Pentra N CONTROL) with the predicate device (ABX 3. Pentra N CONTROL already cleared to market under K052007):
The ABX Pentra N CONTROL was previously described and cleared by the FDA under K052007 and the following submissions K062737, K060205, K060325, K062180, K060854, K060434, K072115, K110137, K110530.
However we have added it in this submission, as it is used in combination with a parameter. The only difference between the previously cleared control and the ones included in this submission is the parameter controlled submitted to the FDA.
| Predicate device (K052007): | Device : | |
|---|---|---|
| Device Name | ABX Pentra N Control | ABX PentraN Control |
| Manufactured by | Roche | Unchanged |
| Commercialized by | HORIBA ABX SAS, France | Unchanged |
| Instrument | ABX PENTRA 400 | Unchanged |
| Method : | Quality control by monitoring accuracy and precisionfor the quantitative methods as specified in theenclosed value sheet- Concentrations and activities are mostly in thenormal or near-normal range | Unchanged |
| Component reagentmatrices | -Vial (lyophilizate)-Human serum with chemical additives and tissueextracts of human and animal origin | Unchanged |
| Biological additives | ALT (GPT), AST (GOT), Albumin, Aldolase,Alkaline phosphatase, Amylase total, PancreaticAmylase, Cholesterol, Cholinesterase, CreatineKinase, Gamma-GT, GLDH, LD (LDH), Lipase, Acidphosphatase, Total proteins | Unchanged |
| Format | Lyophilizate (to reconstitute with distilled/deionisedwater - not provided) | Unchanged |
| Labels | Horiba Medical specific label | Unchanged |
| Notice | Horiba Medical specific notice | Unchanged |
| Packaging | Kit composed of :10 x bottle, each with lyophilizate for 5 ml control | Unchanged |
| Performance data :Theoretical values andconfidence intervals | - The theoretical value specified is the median of thevalues obtained, the confidence interval equals thetheoretical value ± 3SD (SD = Standard | Unchanged |
Similarities :
{6}------------------------------------------------
| Deviation)- The assigned values are indicated in the annexenclosed in the kit.-The values are lot-specific. | ||
|---|---|---|
| Performance data :Closed stability | 30 months at 2-8°C | Unchanged |
| Components** stabilityafter reconstitution ofthe control | At 15-25°C : 12 hoursAt 2-8°C : 5 daysAt (-15°C) - (-25°C) : 4 weeks (when frozen once)**Exceptions:Stability of Total BilirubinAt 15-25°C : 8 hoursAt 2 - 8°C : 24 hoursAt (-15°C)- (-25°C) :2 weeks (when frozen once)Stability of Direct BilirubinAt 15 - 25°C : 4hoursAt 2 - 8°C : 8 hoursAt (-15°C) - (-25°C) :2 weeks (when frozen once) | Unchanged |
Differences :
| Differences : | ||
|---|---|---|
| Predicate device (K052007): | Device : | |
| Device Name | ABX Pentra N Control | ABX Pentra NControl |
| Controlled molecules | The exact control values are given in theenclosed annex | Updated toinclude newapplicationvalues for newarsenazocalcium |
| Controlled molecules : | Applications cleared : | Application notcleared underthis submission: |
| ALP, ALT, Amylase, AST, Creatinekinase, GGT, Lipase, Albumin, DirectBilirubin, Total Bilirubin, Calcium,Chloride, Cholesterol, HDL, LDL,Creatinine 120, Glucose HK, GlucosePAP, Iron, Lactic Acid, Magnesium,Phosphorus, Potassium, Sodium,Total Protein, Total Protein 100,Triglycerides, Urea/BUN, Uric acid,Enzymatic Creatinine, new arsenazocalcium | K060205, CLIA, K062180, K06318,K062737, CLIA, CLIA, K060434,K060325, K060325, K060205,K052007, K060854, K060854,K060854, K072115,K052007,K052007, K060205, CLIA, K060205,K060205, K052007, K052007,K060434, K072115, K060854,K060205, K060205, K110137K110530, - . | - NewarsenazocalciumApplication notcleared (in thissubmission) |
| Value sheet / Annex | Horiba Medical specific annex | New HoribaMedical |
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-
- Comparison of new device (ABX Pentra P CONTROL) with the predicate device (ABX Pentra P CONTROL already cleared to market under K052007):
The ABX Pentra P CONTROL was previously described and cleared by the FDA under K052007 and the following submissions K062737, K060205, K060325, K062180, K060854, K060434, K072115, K110137, K110530.
- Comparison of new device (ABX Pentra P CONTROL) with the predicate device (ABX Pentra P CONTROL already cleared to market under K052007):
However we have added it in this submission, as it is used in combination with a parameter. The only difference between the previously cleared control and the ones included in this submission is the parameter controlled submitted to the FDA.
| Predicate device (K052007): | Device : | |
|---|---|---|
| Device Name | ABX Pentra P Control | ABX PentraP Control |
| Manufactured by | Roche | Unchanged |
| Commercialized by | HORIBA ABX SAS, France | Unchanged |
| Instrument | ABX PENTRA 400 | Unchanged |
| Method : | Quality control by monitoring accuracy and precisionfor the quantitative methods as specified in the enclosedvalue sheetConcentrations and activities are mostly in the normalor near-normal range | Unchanged |
| Component reagentmatrices | Vial (lyophilizate)Human serum with chemical additives and tissueextracts of human and animal origin | Unchanged |
| Biological additives | ALT (GPT), AST (GOT), Albumin, Aldolase, Alkalinephosphatase, Amylase total, Amylase Pancreatic,Cholesterol, Cholinesterase, Creatine Kinase, Gamma-GT, GLDH, LD (LDH), Lipase, Acid phosphatase,Total proteins | Unchanged |
| Format | Lyophilizate (to reconstitute with distilled/deionisedwater - not provided) | Unchanged |
| Labels | Horiba Medical specific label | Unchanged |
| Notice | Horiba Medical specific notice | Unchanged |
| Packaging | Kit composed of :10 x bottle, each with lyophilizate for 5 ml control | Unchanged |
| Performance data :Theoretical values and | - The theoretical value specified is the median of thevalues obtained, the confidence interval equals the | Unchanged |
Similarities :
{8}------------------------------------------------
| confidence intervals | theoretical value ± 3SD (SD = Standard Deviation)- The assigned values are indicated in the annexenclosed in the kit.-The values are lot-specific. | |
|---|---|---|
| Performance data :Closed stability | 30 months at 2-8°C. | Unchanged |
| Performance data :Components** stabilityafter reconstitution ofthe control | At 15-25°C : 12 hours.At 2-8°C : 5 daysAt (-15°C) - (-25°C) : 1 month (when frozen once)**Exceptions:Stability of Total BilirubinAt 15-25°C : 8 hoursAt 2 - 8°C : 24 hoursAt (-15°C)- (-25°C) :2 weeks (when frozen once)Stability of Direct BilirubinAt 15 - 25°C : 4hoursAt 2 - 8°C : 8 hoursAt (-15°C) - (-25°C) :2 weeks (when frozen once) | Unchanged |
·
:
·
.
| Differences : | ||
|---|---|---|
| Predicate device (K052007): | Device : | |
| Device Name | ABX Pentra P Control | ABX Pentra PControl |
| Controlled molecules | The exact control values are given in theenclosed annex | Updated toinclude newapplicationvalues for newarsenazocalcium |
| Controlled molecules : | Applications cleared : | Application notcleared underthissubmission: |
| ALP, ALT, Amylase, AST, Creatinekinase, GGT, Lipase, Albumin, DirectBilirubin, Total Bilirubin, Calcium,Chloride, Cholesterol, HDL, LDL,Creatinine 120, Glucose HK, GlucosePAP, Iron, Lactic Acid, Magnesium,Phosphorus, Potassium, Sodium,Total Protein, Total Protein 100,Triglycerides, Urea/BUN, Uric acid,Enzymatic Creatinine, New arsenazocalcium | K060205, CLIA, K062180, K06318,K062737, CLIA, CLIA, K060434,K060325, K060325, K060205,K052007, K060854, K060854,K060854, K072115, K052007,K052007, K060205, CLIA, K060205,K060205, K052007, K052007,K060434, K072115, K060854,K060205, K060205, K110137 K110530 | New arsenazocalciumApplication notcleared (in thissubmission) |
·
{9}------------------------------------------------
| Value sheet / Annex | Horiba Medical specific annex | New HoribaMedicalspecific annex |
|---|---|---|
| --------------------- | ------------------------------- | ------------------------------------------------ |
-
- Comparison of new device (ABX Pentra URINE CONTROL L/H) with the predicate device (ABX Pentra URINE CONTROL L/H already cleared to market under K070249):
The ABX Pentra URINE CONTROL L/H was previously described and cleared by the FDA under K070249 and the following submission K072115, K110137, K110530.
- Comparison of new device (ABX Pentra URINE CONTROL L/H) with the predicate device (ABX Pentra URINE CONTROL L/H already cleared to market under K070249):
However we have added it in this submission, as it is used in combination with a parameter. The only difference between the previously cleared control and the ones included in this submission is the parameter controlled submitted to the FDA.
| Predicate device (K070249): | Device : | |
|---|---|---|
| Device Name | ABX Pentra Urine Control L/H | ABX PentraUrine ControlL/H |
| Manufactured by | Biorad | Unchanged |
| Commercialized by | HORIBA ABX SAS, France | Unchanged |
| Instrument | ABX PENTRA 400 | Unchanged |
| Method : | Quality control by monitoring accuracy andprecision for the quantitative methods as specifiedin the enclosed value sheet. | Unchanged |
| Component reagentmatrices | Vial (liquid)2 levels : Low / HighHuman urine with added constituents of humanand animal origin, chemicals, preservatives andstabilizers. | Unchanged |
| Format | Liquid, ready to use | Unchanged |
| Labels | Horiba Medical specific label | Unchanged |
| Notice | Horiba Medical specific notice | Unchanged |
| Packaging | Kit composed of :1 x 10 ml Low Control1 x 10 ml High Control | Unchanged |
| Performance data :Theoretical values andconfidence intervals | - The assigned values are determined bycalculating the median value obtained frommultiple determinations.- The assigned values for both Low and Highcontrols are lot specific- The assigned values and precise confidenceinterval are indicated in the annex enclosed in the | Unchanged |
- Similarities :
{10}------------------------------------------------
| COOL COLLECT COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONTROLLERS CONSTITUTION CONSTITUTION CONSTITUTION CONSTITUTION CONSTITUTION CONSTITUTION CONSTITUTION CON | from and controllection of the consisted on the manufactures and consistence and consistence and concerner manus concerner manus concerner manus concerner manus concerner andA-SALEAA LABILIBLASA FRAUBURA LILIBELLUBA BARAUSANI financing and more and more of the more and annual many and estable production and establish briques to relations and established in the manus and management of the managem | AAIliAdt A. C.O.Oblogs A4/0400 A4/018040 Co. Buy BOW YOU CONTENT AN AA. |
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ставления в пристемента с мерека мести приводительные присами принаментации принами принами крастика кактические мательноA CARRENT COLLECTION COLLECTION CARRENAL CLANDS A CLASS COLLECALLACING CALL CALLEMENT PARTIEN PARTIEN PARTIEN PARTIEN PARTIEN PARTIEN PARTIEN PARTIEN PARTIEN PARTIENT PARTIEN | |
| Differences : | |||
|---|---|---|---|
| Predicate device (K070249): | Device : | ||
| Device Name | ABX Pentra Urine Control L/H | ABX Pentra UrineControl L/H | |
| Controlled molecules | The exact control values are givenin the enclosed annex | Updated to includenew applicationvalues for newarsenazo calcium | |
| Controlled molecules : | Applications cleared : | Application notcleared under thissubmission: | |
| Amylase, Calcium, Phosphorus,Glucose HK, Urea/BUN, Uric Acid,Total Proteins (Urinary), Creatinine120, Enzymatic Creatinine, NewArsenazo Calcium | K070249, K070249, K070249,K070146, K070146, K070146,K070146, K072115, K110137K110530, - | New ArsenazoCalcium Applicationnot cleared (in thissubmission) | |
| Value sheet / Annex | Horiba Medical specific annex | New Horiba Medicalspecific annex |
C. Description:
All the reagent, controls and calibrator 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 Calcium AS CP is an in vitro diagnostic assay for the quantitative in vitro determination of calcium in human serum, plasma and urine based on colourimetric method. It is composed of a monoreagent cassette (79 mL). The reagent is chemical solution with additives.
The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer.
This calibrator is provided in ten vials of 3 ml.
The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA
{11}------------------------------------------------
ABX SAS methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.
D. Intended Use:
The reagent in this submission is intended for use on the ABX PENTRA 400.
The controls and calibrator are intended for use in association with the above reagent on the ABX PENTRA 400.
Indications for use:
ABX Pentra Calcium AS CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on a colourimetric method, using the ABX Pentra 400 Clinical Chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
{12}------------------------------------------------
E. Discussion of nonclinical tests submitted:
All the performance studies were conducted using the ABX Pentra 400 clinical chemistry analyzer.
-
- Detection limit
The detection limits are determined according to CLSI (NCCLS), EP17-A protocol: Protocols for determination of limits of detection and limits of quantitation. Approved Guideline, CLSI (NCCLS) document EP17-A (2004) 24 (34). Serum/Plasma : 0.28 mg/dl Urine : 0.23 mg/dl
- Detection limit
-
- Limit of quantitation
The limits of quantitation are determined according to CLSI (NCCLS), EP17-A protocol: Protocols for determination of limits of detection and limits of quantitation. Approved Guideline, CLSI (NCCLS) document EP17-A (2004) 24 (34). Serum/Plasma : 1.54 mg/dl Urine : 0.64 mg/dl
- Limit of quantitation
Repeatability (within-run precision) 3.
3 specimens of low, medium and high concentration and 2 controls are tested 20 times according to the recommendations found in the Valtec protocol : Vassault A. Grafmever D, Naudin C et al. Protocole de validation de techniques (document B). Ann. Biol. Clin. (1986) 44: 686-745.
For serum/plasma
| Mean value (mg/dl) | CV% | |
|---|---|---|
| Control specimen 1 | 8.39 | 0.49 |
| Control specimen 2 | 12.53 | 0.37 |
| Specimen 1 | 6.91 | 0.71 |
| Specimen 2 | 9.18 | 0.40 |
| Specimen 3 | 13.15 | 0.43 |
For urine .
| Mean value (mg/dl) | CV% | |
|---|---|---|
| Control specimen 1 | 7.27 | 0.62 |
| Control specimen 2 | 10.86 | 0.76 |
| Specimen 1 | 7.73 | 0.46 |
| Specimen 2 | 10.50 | 0.56 |
| Specimen 3 | 14.50 | 0.37 |
Reproductibility (total precision) 4.
3 specimens of low, medium and high levels and 2 controls are tested in duplicate for 20 days (2 series per day) according to the recommendations found in the CLSI (NCCLS),
{13}------------------------------------------------
EPS-A2 protocol : Evaluation of Precision Performance of Quantitative Measurement Method. Approved Guideline, CLSI (NCCLS) document EP5-A2 (2004) 24 (25).
For serum/plasma
| Mean value (mg/dl) | CV% | |
|---|---|---|
| Control specimen 1 | 8.72 | 1.44 |
| Control specimen 2 | 13.02 | 1.49 |
| Specimen 1 | 7.03 | 1.56 |
| Specimen 2 | 9.47 | 1.54 |
| Specimen 3 | 12.93 | 1.54 |
For urine
| Mean value (mg/dl) | CV% | |
|---|---|---|
| Control specimen 1 | 7.28 | 1.45 |
| Control specimen 2 | 10.71 | 1.50 |
| Specimen 1 | 7.70 | 1.57 |
| Specimen 2 | 10.27 | 1.57 |
| Specimen 3 | 14.21 | 1.56 |
న. Measuring range
The assay confirmed a measuring range from 4.0 mg/dl - 18.05 mg/dl (for serum/plasma) and 0.64 mg/dl - 18.05 mg/dl (for urine), with an automatic post-dilution up to 54.15 mg/dl.
According to the recommendations found in the CLSI (NCCLS). EP6-A protocol : Evaluation of the Linearity of Quantitative Analytical Methods. Approved Guideline, CLSI (NCCLS) document EP6-A (2003) 23 (16), the reagent linearity for serum/plasma and urine has been assessed up to 18.05 mg/dl. and with automatic post-dilution : 54.15 mg/dl.
-
- Method comparison
According to the recommendations found in the CLSI (NCCLS), EP9-A2 protocol: Method Comparison and Bias Estimation Using Patient Samples. Approved Guideline, 2nd ed., CLSI (NCCLS) document EP9-A2 (2002) 22 (19), patient samples (n=145 for serum/plasma; n=143 for urine) are correlated with a commercial reagent taken as reference.
- Method comparison
Values ranged from 4.17 mg/dl to 15.76 mg/dl for serum/plasma and 0.64 mg/dl to 17.80 mg/dl for urine.
The equations for the allometric line obtained using Passing- Bablock regression procedure: Passing H, Bablock W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. J. Clin. Chem. Clin. Biochem. (1983) 21: 709-20., are:
For serum/plasma: Y = 1.00 x + 0.04 (mg/dl) with r2 = 0.9903 For urine: Y = 0.98 x -0.03 (mg/dl) with r2 = 0.993
{14}------------------------------------------------
7. Matrix comparison study
A matrix comparison study between serum and lithium plasma samples was performed . using 32 paired serum and lithium plasma samples, ranging in calcium concentration from 4.0 mg/dL to 17.5 mg/dL (3 samples were altered). Each sample was tested in singulate using the ABX Pentra Calcium AS CP assay reagent. Linear regression analysis of the plot of serum (x-axis) and lithium plasma (y-axis) samples showed the following relationships between the matrix types: y = 1.006x - 0.0022, r2 = 0.996
8. Calibration stability
The reagent is calibrated on Day 0. The calibration stability is checked by testing 2 control specimens.
The calibration stability is 10 days for serum/plasma and urine.
A recalibration is recommended when reagent lots change, and when quality control results fall outside the range established.
9. Reagent stability
.
.
Closed stability: 24 months at 2-8℃ On-board stability: 60 days at 2-8°C
| ABX PENTRA Multical: | |||
|---|---|---|---|
| Analytes | Already cleared(K052007, K060205, K060318,K060325, K060854, K062180,K062737, K060434, K072115,K110137, K110530) | Included in this submission | |
| Alkaline phosphatase | √ | √ | |
| Alanine aminotransferase | √ | √ | |
| Amylase | √ | √ | |
| Aspartate aminotransferase | √ | √ | |
| Creatine kinase | √ | √ | |
| GGT | √ | √ | |
| LDH | √ | √ | |
| Lipase | √ | √ | |
| Albumin | √ | √ | |
| Direct Bilirubin | √ | √ | |
| Total Bilirubin | √ | √ | |
| Calcium | √ | √ | |
| New Calcium AS | √ | ||
| Cholesterol | √ | √ | |
| Creatinine 120 | √ | √ | |
| Enzymatic Creatinine CP | √ | √ |
F. CALIBRATOR
{15}------------------------------------------------
| ABX PENTRA Multical: | ||
|---|---|---|
| Glucose HK | √ | √ |
| Glucose PAP | √ | √ |
| Iron | √ | √ |
| Lactic acid | √ | √ |
| Magnesium | √ | √ |
| Phosphorus | √ | √ |
| Total Protein | √ | √ |
| Total Protein 100 | √ | √ |
| Triglycerides | √ | √ |
| Urea / Blood Urea Nitrogen | √ | √ |
| Uric acid | √ | √ |
| Format | Lyophilized human serum with chemical additives and materials of biological origin | |
| Stability | Closed stability: 24 months at 2-8°COpen stability:Once opened, the calibrator components** are stable for:8 hours at 15°C to 25°C2 days at 2°C to 8°C2 weeks at -25°C to -15°C**ExceptionsDirect Bilirubin3 hours at 15°C to 25°C8 hours at 2°C to 8°C2 weeks at -25°C to -15°CTotal Bilirubin6 hours at 15°C to 25°C1 day at 2°C to 8°C |
G. CONTROLS
.
:
| Analytes | Already cleared(K052007, K060205, K060318,K060325, K060854, K062180,K062737, K060434, K072115,K110137, K110530) | Included in this submission |
|---|---|---|
| Alkaline phosphatase | √ | √ |
| Alanine aminotransferase | √ | √ |
| Amylase | √ | √ |
| Aspartate aminotransferase | √ | √ |
| Creatine kinase | √ | √ |
| GGT | √ | √ |
| LDH | √ | √ |
| Lipase | √ | √ |
・
HORIBA ABX SAS, FRANCE
.
:
{16}------------------------------------------------
| ABX PENTRA N Control: | ||
|---|---|---|
| Albumin | √ | √ |
| Direct Bilirubin | √ | √ |
| Total Bilirubin | √ | √ |
| Calcium | √ | √ |
| New Calcium AS | √ | |
| Chloride | √ | √ |
| Cholesterol | √ | √ |
| HDL | √ | √ |
| LDL | √ | √ |
| Creatinine 120 | √ | √ |
| Enzymatic Creatinine CP | √ | √ |
| Glucose HK | √ | √ |
| Glucose PAP | √ | √ |
| Iron | √ | √ |
| Lactic acid | √ | √ |
| Magnesium | √ | √ |
| Phosphorus | √ | √ |
| Potassium | √ | √ |
| Sodium | √ | √ |
| Total Protein | √ | √ |
| Total Protein 100 | √ | √ |
| Triglycerides | √ | √ |
| Urea / Blood Urea Nitrogen | √ | √ |
| Uric acid | √ | √ |
.../...
| Format | Lyophilized human serum with chemical additives and materials of biological origin |
|---|---|
| Stability | Closed stability: 30 months at 2-8°C |
| Open stability: | |
| Once opened, the control components** are stable for: | |
| 12 hours at 15°C to 25°C | |
| 5 days at 2°C to 8°C | |
| 1 month at -25°C to -15°C | |
| **Exceptions | |
| Direct Bilirubin | |
| 4 hours at 15°C to 25°C | |
| 8 hours at 2°C to 8°C | |
| 2 weeks at -25°C to -15°C | |
| Total Bilirubin | |
| 8 hours at 15°C to 25°C | |
| 1 day at 2°C to 8°C | |
| 2 weeks at -25°C to -15°C |
.
HORIBA ABX SAS, FRANCE
{17}------------------------------------------------
| ABX PENTRA P Control: | ||
|---|---|---|
| Analytes | Already cleared(K052007, K060205, K060318,K060325, K060854, K062180,K062737, K060434, K072115,K110137, K110530) | Included in this submission |
| Alkaline phosphatase | √ | √ |
| Alanine aminotransferase | √ | √ |
| Amylase | √ | √ |
| Aspartate aminotransferase | √ | √ |
| Creatine kinase | √ | √ |
| GGT | √ | √ |
| LDH | √ | √ |
| Lipase | √ | √ |
| Albumin | √ | √ |
| Direct Bilirubin | √ | √ |
| Total Bilirubin | √ | √ |
| Calcium | √ | √ |
| New Calcium AS | √ | |
| Chloride | √ | √ |
| Cholesterol | √ | √ |
| HDL | √ | √ |
| LDL | √ | √ |
| Creatinine 120 | √ | √ |
| Enzymatic Creatinine CP | √ | √ |
| Glucose HK | √ | √ |
| Glucose PAP | √ | √ |
| Iron | √ | √ |
| Lactic acid | √ | √ |
| Magnesium | √ | √ |
| Phosphorus | √ | √ |
| Potassium | √ | √ |
| Sodium | √ | √ |
| Total Protein | √ | √ |
| Total Protein 100 | √ | √ |
| Triglycerides | √ | √ |
| Urea / Blood Urea Nitrogen | √ | √ |
| Uric acid | √ | √ |
| Format | Lyophilized human serum with chemical additives and materialof biological origin | |
| Stability | Closed stability: 30 months at 2-8°COpen stability:Once opened, the control components** are stable for :12 hours at 15°C to 25°C | |
| ABX PENTRA P Control: | ||
| 1 month at -25°C to -15°C | .../... | |
| **Exceptions | ||
| Direct Bilirubin | ||
| 4 hours at 15°C to 25°C | ||
| 8 hours at 2°C to 8°C | ||
| 2 weeks at -25°C to -15°C | ||
| Total Bilirubin | ||
| 8 hours at 15°C to 25°C | ||
| 1 day at 2°C to 8°C | ||
| 2 weeks at -25°C to -15°C. |
. HORIBA ABX SAS, FRANCE
:
.
:
.
{18}------------------------------------------------
| ABX PENTRA Urine Control L/H: | ||
|---|---|---|
| Analytes | Already cleared (K07249,K072115, K110137, K110530) | Included in this submission |
| Amylase | √ | √ |
| Calcium | √ | √ |
| New Calcium AS | √ | |
| Creatinine 120 | √ | √ |
| Enzymatic Creatinine CP | √ | √ |
| Phosphorus | √ | √ |
| Glucose | √ | √ |
| Urea / Blood Urea Nitrogen | √ | √ |
| Uric acid | √ | √ |
| Urinary proteins | √ | √ |
| FormatStability | Liquid solution prepared from human urine with chemicaladditives and materials of biological originClosed stability: 2 years at 2-8°COpen stability: 30 days at 2-8°C |
. Conclusions for Performance Testing:
11.11
The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that the devices are substantially equivalent to their respective predicate devices. : .
.
· ·
.
{19}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/19/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wave-like lines beneath it.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 3, 2013
Horiba ABX SAS C/O Caroline Ferrer Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE
Re: K123171
Trade/Device Name: ABX PENTRA CALCIUM AS CP, ABX PENTRA Multical, ABX PENTRA N Control, ABX PENTRA P Control, ABX PENTRA Urine Control L/H
Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: II Product Code: CJY, JIX, JJY Dated: May 17, 2013 Received: May 20, 2013
Dear Ms. Ferrer:
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. 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.
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); medical device reporting (reporting of medical
{20}------------------------------------------------
Page 2-Ms. Ferrer
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{21}------------------------------------------------
510(k) Number (if known): K123171
Device Name: ABX Pentra Calcium AS CP
Indications for Use:
ABX Pentra Calcium AS CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on a colourimetric method, using the ABX Pentra 400 Clinical Chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Prescription Use _ X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung W. Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K123171
{22}------------------------------------------------
510(k) Number (if known): K123171
Device Name: ABX PENTRA Multical
Indications for Use:
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
Prescription Use _X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung W. Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K123171
Page 2 of 5
{23}------------------------------------------------
510(k) Number (if known): K123171
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 of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
YungW.Chan-S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k)_k123171
Page 3 of 5
{24}------------------------------------------------
510(k) Number (if known): K123171
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 of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
Prescription Use _ X (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
YungW.Chan-s
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) = K123171
{25}------------------------------------------------
510(k) Number (if known): K123171
Device Name: ABX PENTRA Urine Control L/H .
Indications for Use:
The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
Prescription Use _ X (21 CFR Part 801 Subpart D)
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung W. Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K123171 510(k)
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. 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).(b)
Classification. Class II.