(357 days)
The Carbamazepine is intended for the quantitative in vitro diagnostic determination of the carbamazepine concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to help ensure proper therapy.
The Valproic Acid is intended for the quantitative in vitro diagnostic determination of the valproic acid concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to help ensure proper therapy.
TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981645 Carbamazepine and kit code 981650 Valproic acid assays on T60 Analyzer.
Not Found
The provided text describes the 510(k) submission for Thermo Fisher Scientific Oy's Carbamazepine and Valproic Acid test systems and TDM Calibration set B. The document outlines the intended use, indications for use, and a comparison with predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are primarily in comparison to a predicate device, focusing on similar performance characteristics. The document presents performance data for "New device #1" (Thermo Fisher Scientific Oy's device) and "Predicate device #1" (Microgenics Corporation CEDIA® Carbamazepine II/Valproic Acid II).
Carbamazepine Assay:
| Attribute | Acceptance Criteria (Predicate Device #1) | Reported Device Performance (New Device #1) |
|---|---|---|
| Intended Use | For quantitation of carbamazepine in human serum or plasma using automated clinical chemistry analyzers, for diagnosis and treatment of overdose and monitoring levels to ensure proper therapy. | For quantitative determination of carbamazepine concentration in human serum on T60 analyzer, for diagnosis and treatment of overdose and monitoring levels to help ensure proper therapy. |
| Indications for Use | Same as Intended Use. | For quantitative in vitro diagnostic determination of carbamazepine concentration in human serum using T60 Clinical Chemistry Analyzers, for diagnosis and treatment of overdose and monitoring levels to help ensure proper therapy. |
| Assay Protocol | Recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. | Recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. |
| Traceability/Standardization | Calibration values traceable to USP reference materials prepared gravimetrically to drug-free human serum. | Calibration values are traceable to USP reference materials prepared gravimetrically to drug-free human serum. |
| Sample Type | Serum or plasma (Na or Li heparin, Na EDTA). | Human Serum. |
| Reagent Storage | Store at 2-8 °C. Do not freeze. Stability of unopened components indicated on labels. | Unopened reagents stable at 2-8 °C until expiration date. DO NOT FREEZE. |
| Expected Values (Therapeutic Range for adults) | Ranges such as 5-12 µg/ml, 8-12 µg/ml, 3-12 µg/ml, 6-10 µg/ml, 4-10 µg/ml, 4-8 µg/ml, 4-12 µg/ml. | Suggested ranges: 4 - 12 µg/ml or 17 - 51 µmol/l (1); 4 - 10 µg/ml or 17 - 42 µmol/l (2). |
| Measuring Range | Between 0.5 µg/ml and approximately 20 µg/ml. | From 1.0 µg/ml to 19.0 µg/ml. |
| Precision | Within run: Level 4.2 µg/ml (SD=0.06, CV=1.5%), Level 10.6 µg/ml (SD=0.08, CV=0.8%), Level 16.8 µg/ml (SD=0.12, CV=0.7%). Total: Level 4.2 µg/ml (SD=0.15, CV=3.5%), Level 10.6 µg/ml (SD=0.21, CV=2.0%), Level 16.8 µg/ml (SD=0.29, CV=1.7%). | Within run: Level 3.0 µg/ml (SD=0.09, CV=2.8%), Level 9.5 µg/ml (SD=0.14, CV=1.5%), Level 15.0 µg/ml (SD=0.16, CV=1.1%). Between run: Level 3.0 µg/ml (SD=0.07, CV=2.4%), Level 15.0 µg/ml (SD=0.14, CV=0.9%). Total: Level 3.0 µg/ml (SD=0.19, CV=6.3%), Level 9.5 µg/ml (SD=0.32, CV=3.3%), Level 15.0 µg/ml (SD=0.42, CV=2.8%). |
| Method Comparison (Deming Regression) | Y = 1.04x - 0.04; r = 0.999; Sy.x = 0.26; Range 1.3 - 19.8 µg/ml; N = 103 (vs. previous CEDIA Carbamazepine assay). | y = 0.98 x + 0.02; r = 0.993; Range 1.9 - 19.6 µg/ml; N = 134. |
| Limitations (Interference) | Hemoglobin up to 1000 mg/dl, Bilirubin up to 66 mg/dl, Triglyceride up to 1000 mg/dl, Total protein up to 12 g/dl, Rheumatoid factor up to 180 IU/ml. | No interference found: Hemoglobin up to 1000 mg/dl, Bilirubin up to 58 mg/dl, Lipemia up to 1000 mg/dl of Intralipid®. |
Valproic Acid Assay:
| Attribute | Acceptance Criteria (Predicate Device #1) | Reported Device Performance (New Device #1) |
|---|---|---|
| Intended Use | For quantitation of valproic acid in human serum or plasma using automated clinical chemistry analyzers, for diagnosis and treatment of overdose and monitoring levels to ensure proper therapy. | For quantitative determination of valproic acid concentration in human serum on T60 instrument, for diagnosis and treatment of overdose and monitoring levels to help ensure proper therapy. |
| Indications for Use | Same as Intended Use. | For quantitative in vitro diagnostic determination of valproic acid concentration in human serum using T60 Clinical Chemistry Analyzers, for diagnosis and treatment of overdose and monitoring levels to help ensure proper therapy. |
| Assay Protocol | Recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. | Recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. |
| Traceability/Standardization | Calibration values traceable to USP reference materials prepared gravimetrically to drug-free human serum. | Calibration values are traceable to USP reference materials prepared gravimetrically to drug-free human serum. |
| Sample Type | Serum or plasma (Na or Li heparin, Na EDTA). | Human Serum. |
| Reagent Storage | Store at 2-8 °C. Do not freeze. Stability of unopened components indicated on labels. | Unopened reagents stable at 2-8 °C until expiration date. DO NOT FREEZE. |
| Expected Values (Therapeutic range for adults) | Ranges such as 50-100 µg/ml, 40-90 µg/ml. Toxic >100 µg/ml. | 50 - 100 µg/ml or 347 - 693 µmol/l (1,2). |
| Measuring Range | Between 3.0 µg/ml and approximately 150 µg/ml. | From 3.0 µg/ml to 142.5 µg/ml. |
| Precision | Within run: Level 24.4 µg/ml (SD=0.59, CV=2.4%), Level 95.0 µg/ml (SD=1.43, CV=1.5%), Level 136.8 µg/ml (SD=1.81, CV=1.3%). Total: Level 24.4 µg/ml (SD=0.83, CV=3.4%), Level 95.0 µg/ml (SD=1.93, CV=2.0%), Level 136.8 µg/ml (SD=2.48, CV=1.8%). | Within run: Level 35.0 µg/ml (SD=0.43, CV=1.2%), Level 81.1 µg/ml (SD=0.81, CV=1.0%), Level 113.6 µg/ml (SD=1.01, CV=0.9%). Between run: Level 35.0 µg/ml (SD=0.61, CV=1.8%), Level 81.1 µg/ml (SD=1.08, CV=1.3%), Level 113.6 µg/ml (SD=1.07, CV=0.9%). Total: Level 35.0 µg/ml (SD=1.90, CV=5.4%), Level 81.1 µg/ml (SD=3.15, CV=3.9%), Level 113.6 µg/ml (SD=3.11, CV=2.7%). |
| Method Comparison (Deming Regression) | Y = 1.08x - 0.61; r = 0.972; Sy.x = 7.042; Range 2.6 - 119.8 µg/ml; N = 77 (vs. commercially available fluorescence polarization immunoassay). | y = 0.996 x + 1.4; r = 0.993; Range 3.2 - 143.4 µg/ml; N = 136. |
| Limitations (Interference) | Hemoglobin up to 1000 mg/dl, Bilirubin up to 60 mg/dl, Triglyceride up to 1000 mg/dl, Total protein up to 10 g/dl, IgA up to 790 mg/dl, IgG up to 4300 mg/dl, IgM up to 840 mg/dl, Rheumatoid factor up to 200 IU/ml. | No interference found: Hemoglobin up to 1000 mg/dl, Bilirubin up to 58 mg/dl, Lipemia up to 1000 mg/dl of Intralipid®. |
2. Sample sizes used for the test set and the data provenance
- Carbamazepine:
- Method Comparison (test set): N = 134 samples (Carbamazepine).
- Provenance: Not explicitly stated, but clinical chemistry assays typically use de-identified human serum samples. The document doesn't specify if the data is retrospective or prospective, or the country of origin.
- Valproic Acid:
- Method Comparison (test set): N = 136 samples (Valproic Acid).
- Provenance: Not explicitly stated, but clinical chemistry assays typically use de-identified human serum samples. The document doesn't specify if the data is retrospective or prospective, or the country of origin.
- Precision (Carbamazepine & Valproic Acid): Tested at multiple levels (3 for each assay). The number of replicates or runs to achieve the reported SD and CV values is not explicitly stated in this summary but is typically part of the full validation report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For these types of quantitative in vitro diagnostic devices, "ground truth" is typically established by comparing the device's measurements against a recognized reference method or a predicate device that has established accuracy, rather than expert consensus on a clinical diagnosis. The predicate device's performance data is used as the comparative "truth" for demonstrating substantial equivalence.
4. Adjudication method for the test set
This is not applicable/provided as the study focuses on quantitative measurement comparison rather than diagnostic interpretation requiring adjudication. The method comparison studies for both Carbamazepine and Valproic Acid used Deming regression to compare the new device's measurements against the predicate device's measurements.
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
This is not applicable. This document describes an in vitro diagnostic device (a laboratory test for drug levels) and not an imaging or interpretive AI-driven diagnostic system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes a standalone in vitro diagnostic system (reagents and an analyzer) which performs quantitative measurements of drug concentrations. The results are then used by healthcare professionals for diagnosis and treatment. In this context, the "standalone" performance refers to the analytical performance of the device itself (precision, measuring range, method comparison) as detailed in the tables. There isn't an "algorithm only" component in the sense of a software-AI device, but rather a chemical assay coupled with an automated analyzer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the method comparison studies was the measurements obtained from the predicate devices (CEDIA® Carbamazepine II and a commercially available fluorescence polarization immunoassay for Valproic Acid). For precision studies, "truth" is established by the known concentrations of quality control materials. The overall goal is to demonstrate that the new device's measurements correlate closely with these established methods.
8. The sample size for the training set
This information is not provided in the summary. For in vitro diagnostic assays, "training set" is usually not explicitly defined in the same way as for AI/ML models. Assay development and optimization involve extensive testing with various samples, but this isn't typically presented as a distinct "training set" in 510(k) summaries for traditional IVDs.
9. How the ground truth for the training set was established
This information is not provided for the reasons mentioned in point 8.
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Image /page/0/Picture/0 description: The image contains the logo for Thermo Fisher Scientific. The logo is composed of two lines of text. The first line is the company name, "ThermoFisher", in a bold, sans-serif font. The second line is the word "SCIENTIFIC" in a smaller, sans-serif font.
0CT 5 " 2007
510(k) SUMMARY
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: K063131
Introduction: A.
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
B. Submitter
Thermo Fisher Scientific Oy Ratastie 2 P.O. Box 100 FIN-01621 Vantaa Finland +358 (9) 329 100 tel +358 (9) 3291 0500 fax Contact: Päivi Sormunen, Vice President of QRC Date of Preparation: September 25, 2007
C. Device name
Proprietary name: Carbamazepine Common name: Carbamazepine test system Classification: II Class: Toxicology Product Code: KLT
Proprietary name: Valproic Acid Common name: Valproic Acid test system Classification: II Class: Toxicology Product Code: LEG
Proprietary name: TDM Calibration set B Common name: Calibrator Classification: II Class: Toxicology Product Code: DKB
Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki
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D. Intended Use
Carbamazepine
For in vitro diagnostic use in the quantitative determination of the carbamazepine concentration in human serum on T60 analyzer. Measurements are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to help ensure proper therapy.
Valproic Acid
For in vitro diagnostic use in the quantitative determination of the valproic acid concentration in human serum on T60 instrument. Measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to help ensure proper therapy.
TDM Calibration set B
For in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981645 Carbamazepine and kit code 981650 Valproic acid assays on T60 Analyzer.
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E. Indications for use
The Carbamazepine is intended for the quantitative in vitro diagnostic determination of the carbamazepine concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to help ensure proper therapy.
The Valproic Acid is intended for the quantitative in vitro diagnostic determination of the valproic acid concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to help ensure proper therapy.
TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981645 Carbamazepine and kit code 981650 Valproic acid assays on T60 Analyzer.
F. Substantial Equivalence
CEDIA® Carbamazepine II Microgenics Corporation
CEDIA® Valproic acid II Microgenics Corporation
Substantial equivalence -similarities G.
T60 Carbamazepine and Valproic Acid are substantially equivalent to other devices legally marketed in United Staes. We claim equivalence to the Microgenics Corporation CEDIA® Carbamazepine II and CEDIA® Valproic acid II
Y -tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki
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| Attribute | New device #1 | Predicate device #1 |
|---|---|---|
| Intended Use | For in vitro diagnostic use in thequantitative determination of thecarbamazepine concentration in humanserum on T60 analyzer. Measurementsare used in the diagnosis and treatment ofcarbamazepine overdose and inmonitoring levels of carbamazepine tohelp ensure proper therapy. | The CEDIA® Carbamazepine IIhomogeneous enzyme immunoassayis for the quantitation ofcarbamazepine in human serum orplasma using automated clinicalchemistry analyzers. Measurementsare used in the diagnosis andtreatment of carbamazepineoverdose and in monitoring levels ofcarbamazepine to ensure propertherapy. |
| Indication for Use | The Carbamazepine is intended forthe quantitative in vitro diagnosticdetermination of the carbamazepineconcentration in human serum usingT60 Clinical Chemistry Analyzers.Measurements are used in thediagnosis and treatment ofcarbamazepine overdose and inmonitoring levels of carbamazepineto help ensure proper therapy. | See Intended Use |
| Assay Protocol | Assay uses recombinant DNAtechnology (US Patent no. 4708929)to produce a unique homogenousenzyme immunoassay system. | Assay uses recombinant DNAtechnology (US Patent no. 4708929)to produce a unique homogenousenzyme immunoassay system. |
| Traceability/Standardization | The calibration values are traceable toUSP reference materials preparedgravimetrically to drug-free humanserum. | The calibration values are traceableto USP reference materials preparedgravimetrically to drug-free humanserum. |
| Sample Type | Human Serum | Serum or plasma (Na or Li heparin,Na EDTA) |
| Reagent Storage | The unopened reagents are stable at2...8 °C until the expiration datestated on the label. Refer to theApplication Notes of your T60analyzer for the on board stability ofreagents.DO NOT FREEZE the unopenedreagents or the reconstituted reagents. | Store CEDIA Carbamazepine IIreagents at 2-8 °C. Do not freeze.For stability of the unopenedcomponents refer to the box orbottle labels for the expiration date |
| The following table compares the Carbamazepine with the predicate test system | ||||
|---|---|---|---|---|
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| Attribute | New device #1 | Predicate device #1 |
|---|---|---|
| Expected Values | Therapeutic range for adults:According to different sources thesuggested ranges are:4 - 12 µg/ml or 17 - 51 µmol/l (1)4 - 10 µg/ml or 17 - 42 µmol/l (2) | Therapeutic Range (µg/ml)Penry and Newmark 5-12Scheuer and Pedley 8-12Troupin et al 8-12Strandjord and Johannessen 3-12Simonsen et al 6-10Larkin et al 4-10Shorvon et al 4-8MacKichan and Kutt 4-12 |
| Instrument | T60, DPC T60i, and DPC T60i Kusti | Roche Hitachi 911/912 |
| Measuring Range | From 1.0 µg/ml to 19.0 µg/ml. | Between 0.5 µg/ml and the value ofthe Core TDM Multi-Cal HighCalibrator (approximately 20 µg/mlor 84.6 µmol/l). |
| Precision | Within runLevel 3.0 µg/mlSD = 0.09CV(%) = 2.8Level 9.5 µg/mlSD = 0.14CV(%) = 1.5Level 15.0 µg/mlSD = 0.16CV(%) = 1.1Between runLevel 3.0 µg/mlSD = 0.07CV(%) = 2.4Level 9.5 µg/mlSD = -CV(%) = -Level 15.0 µg/mlSD = 0.14CV(%) = 0.9TotalLevel 3.0 µg/mlSD = 0.19CV(%) = 6.3Level 9.5 µg/mlSD = 0.32CV(%) = 3.3Level 15.0 µg/mlSD = 0.42CV(%) = 2.8 | Within runLevel 4.2 µg/mlSD = 0.06CV(%) = 1.5Level 10.6 µg/mlSD = 0.08CV(%) = 0.8Level 16.8 µg/mlSD = 0.12CV(%) = 0.7TotalLevel 4.2 µg/mlSD = 0.15CV(%) = 3.5Level 10.6 µg/mlSD = 0.21CV(%) = 2.0Level 16.8 µg/mlSD = 0.29CV(%) = 1.7 |
| Attribute | New device #1 | Predicate device #1 |
| Method Comparison | (Unit µg/ml)Deming:$y = 0.98 x + 0.02$$r = 0.993$Range 1.9 - 19.6 µg/mlN = 134 | Previous CEDIA Carbamazepineassay (x). Correlation (µg/ml)(Deming's):$Y =1.04x -0.04$$r = 0.999$Sy.x = 0.26Range 1.3 - 19.8 µg/mlN = 103 |
| Limitations | No interference foundHemoglobin:up to 1000 mg/dl (10 g/l).Bilirubin:up to 58 mg/dl (1000 µmol/l)Lipemia:up to 1000 mg/dl (10 g/l) ofIntralipid® | Samples containing carbamazepineand the following concentrations ofpotential interference substanceswere quantitated accurately by theCEDIA® Carbamazepine II assay:Hemoglobin up to 1000 mg/dl,Bilirubin up to 66 mg/dl,Triglyceride up to 1000 mg/dl,Total protein up to 12 g/dl,Rheumatoid factor up to 180 IU/ml |
| Attribute | New device #1 | Predicate device #1 |
| Intended Use | For in vitro diagnostic use in thequantitative determination of the valproicacid concentration in human serum onT60 instrument. Measurements are usedin the diagnosis and treatment of valproicacid overdose and in monitoring levels ofvalproic acid to help ensure propertherapy. | The CEDIA® Valproic Acid IIhomogeneous enzyme immunoassayis for the quantitation of valproicacid in human serum or plasmausing automated clinical chemistryanalyzers. Measurements are used asan aid in the diagnosis and treatmentof valproic acid overdose and inmonitoring levels of valproic acid toensure proper therapy. |
| Indication for Use | The Valproic Acid is intended for thequantitative in vitro diagnosticdetermination of the valproic acidconcentration in human serum usingT60 Clinical Chemistry Analyzers.Measurements are used in thediagnosis and treatment of valproicacid overdose and in monitoringlevels of valproic acid to help ensureproper therapy. | See Intended Use |
| Assay Protocol | Assay uses recombinant DNAtechnology (US Patent no. 4708929)to produce a unique homogenousenzyme immunoassay system. | Assay uses recombinant DNAtechnology (US Patent no. 4708929)to produce a unique homogenousenzyme immunoassay system. |
| Traceability/Standardization | The calibration values are traceable toUSP reference materials preparedgravimetrically to drug-free humanserum. | The calibration values are traceableto USP reference materials preparedgravimetrically to drug-free humanserum. |
| Sample Type | Human Serum | Serum or plasma (Na or Li heparin,Na EDTA) |
| Reagent Storage | The unopened reagents are stable at2...8 °C until the expiration datestated on the label.DO NOT FREEZE the unopenedreagents or the reconstituted reagents. | Store CEDIA® Valproic acid IIreagents at 2-8 °C. Do not freeze.For stability of the unopenedcomponents refer to the box orbottle labels for the expiration date |
Ratastie 2
P.O. Box 100
FIN-01621 Vantaa
Finland
+358 (9) 329 100 tel
· 358 (9) 3291 0500 fax
Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki
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SCIENTIFIC
Thermo Fisher Scientific Oy
Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki
www.thermo com
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| Predicate Test System | Valproic Acid |
|---|---|
| $\frac{d[Drug]}{dt} = k_{in} - k_{out}*[Drug]$ | $\frac{d[Drug]}{dt} = k_{in} - k_{out}[Drug] - k_{met}[Drug]$ |
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| Attribute | New device #1 | Predicate device #1 |
|---|---|---|
| Expected Values | Therapeutic range for adults:50 - 100 µg/ml or347 - 693 µmol/l (1,2) | TherapeuticSchobben et al 50-100 µg/mlCloyd and Leppik 50-100 µg/mlKlotz and Schweizer 40-90 µg/mlTurnbull et al 50-100 µg/mlToxicSchobben et al - µg/mlCloyd and Leppik >100 µg/mlKlotz and Schweizer -Turnbull et al >100 µg/ml |
| Instrument | T60, DPC T60i, and DPC T60i Kusti | Roche Hitachi 911/912 |
| Measuring Range | From 3.0 µg/ml to 142.5 µg/ml. | Between 3.0 µg/ml and the value ofthe Core TDM High Calibrator(approximately 150 µg/ml or 1039.5 µmol/l) |
| Precision | Within runLevel 35.0 µg/mlSD = 0.43CV(%) = 1.2Level 81.1 µg/mlSD = 0.81CV(%) = 1.0Level 113.6 µg/mlSD = 1.01CV(%) = 0.9Between runLevel 35.0 µg/mlSD = 0.61CV(%) = 1.8Level 81.1 µg/mlSD = 1.08CV(%) = 1.3Level 113.6 µg/mlSD = 1.07CV(%) = 0.9TotalLevel 35.0 µg/mlSD = 1.90CV(%) = 5.4Level 81.1 µg/mlSD = 3.15CV(%) = 3.9Level 113.6 µg/mlSD = 3.11CV(%) = 2.7 | Within runLevel 24.4 µg/mlSD = 0.59CV(%) = 2.4Level 95.0 µg/mlSD = 1.43CV(%) = 1.5Level 136.8 µg/mlSD = 1.81CV(%) = 1.3TotalLevel 24.4 µg/mlSD(µg/ml) = 0.83CV(%) = 3.4Level 95.0 µg/mlSD = 1.93CV(%) = 2.0Level 136.8 µg/mlSD = 2.48CV(%) = 1.8 |
| Attribute | New device #1 | Predicate device #1 |
| Method Comparison | (Unit µg/ml)Deming:$y = 0.996 x + 1.4$$r = 0.993$Range 3.2 - 143.4 µg/mlN = 136 | Commercially availablefluorescence polarizationimmunoassay (x)Correlation (µg/ml)(Linear regression):$Y = 1.08x -0.61$$r = 0.972$$Sy.x = 7.042$Range 2.6 - 119.8 µg/mlN = 77 |
| Limitations | No interference foundHemoglobin:up to 1000 mg/dl (10 g/l).Bilirubin:up to 58 mg/dl (1000 µmol/l)Lipemia:up to 1000 mg/dl (10 g/l) ofIntralipid® | Samples containing valproic acidand the following concentrations ofpotential interference substanceswere quantitated accurately by theCEDIA Valproic Acid II assay:Hemoglobin up to 1000 mg/dl,Bilirubin up to 60 mg/dl,Triglyceride up to 1000 mg/dl,Total protein up to 10 g/dl,IgA up to 790 mg/dlIgG up to 4300 mg/dl,IgM up to 840 mg/dl andRheumatoid factor up to 200 IU/ml |
Thermo Fisher Scientific Oy
Ratastie 2
P.O. Box 100
FIN-01621 Vantaa
Finland
+358 (9) 329 100 tcl
+358 (9) 3291 0500 fax
Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki
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S C
+358 (9) 329 100 tel
+358 (9) 3291 0500 fax
u www.thermo com
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Image /page/9/Picture/1 description: The image shows a circular logo with an eagle in the center. The eagle is stylized with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. The logo appears to be a seal or emblem, possibly representing a government agency.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Thermo Fisher Scientific Oy c/o Mr. Päivi Sormunen Vice President of ORC Ratastie 2, P.O. Box 100 FIN-01621 Vantaa, Finland
OCT 5 2007
Re: K063131 Trade Name: Carbamazepine, Valproic Acid and TDM Calibration set B Regulation Number: 21 CFR 862.3645 Regulation Name: Neuroleptic drugs radioreceptor assay test system. Regulatory Class: Class II Product Code: KLT, LEG, DKB Dated: September 25, 2007 Received: September 27, 2007
Dear Mr. Sormunen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (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 can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that 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 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Coopes, M.S., D.v.M.
Jéan M. Cooper, M.S., D.V.M. 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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Indications for Use
510(k) Number (if known): K063131
Device Names: Carbamazepine Valproic Acid TDM Calibration set B
Indications for Use:
The Carbamazepine is intended for the quantitative in vitro diagnostic determination of the carbamazepine concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to help ensure proper therapy
The Valproic Acid is intended for the quantitative in vitro diagnostic determination of the valproic acid concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to help ensure proper therapy.
TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981645 Carbamazepine and kit code 981650 Valproic acid assays on T60 Analyzer.
Prescription Use × (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
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Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
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510(k)
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Office of In Vitro Diagnostic Device Evaluation and Safety
S10(k) |K06313|
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.