TDM CONTROL SET
Device Facts
| Record ID | K060429 |
|---|---|
| Device Name | TDM CONTROL SET |
| Applicant | Roche Diagnostics Corp. |
| Product Code | JJY · Clinical Chemistry |
| Decision Date | Mar 15, 2006 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 862.1660 |
| Device Class | Class 1 |
Intended Use
The TDM Control Set is intended for use as an assayed quality control product on Roche/Hitachi and COBAS INTEGRA analyzers. Three assayed levels of acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetyl procainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid and vancomycin are provided.
Device Story
TDM Control Set is a human serum-based liquid quality control product containing seventeen therapeutic drugs, preservatives, and stabilizers. It is provided in three levels (I, II, III) for use on Roche/Hitachi and COBAS INTEGRA analyzers. The device serves as an assayed control to verify the accuracy and precision of TDM assays in clinical laboratory settings. Healthcare providers use the control results to validate that the analyzer is performing within established target ranges for each analyte before testing patient samples. This ensures the reliability of therapeutic drug monitoring, which is critical for adjusting patient dosages and preventing toxicity or sub-therapeutic levels.
Clinical Evidence
No clinical data. Bench testing only. Stability studies performed for unopened (accelerated) and opened (real-time) vials. Unopened stability verified by storage at elevated temperatures (45°C, 37°C, 32°C) with recovery within 95-105% of reference. Opened stability verified over 120 days with recovery within ±5% of newly opened vials.
Technological Characteristics
Human serum-based liquid control; contains seventeen therapeutic drugs, preservatives, and stabilizers. Analyte values are traceable to USP standards. Assigned using Hitachi 917, Module P, and COBAS Integra 400/700/800 analyzers. Storage requirements: 2-8°C.
Indications for Use
Indicated for use as an assayed quality control material for monitoring the performance of therapeutic drug monitoring (TDM) assays on Roche/Hitachi and COBAS INTEGRA analyzers. Prescription use only.
Regulatory Classification
Identification
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
Predicate Devices
- CLINIQA Liquid QC TDM Controls Levels, 1, 2, & 3 (k041898)
Related Devices
- K070200 — TDM CONTROL SET, MODEL CAT# 04521536 · Roche Diagnostics Corp. · Mar 19, 2007
- K031856 — PRECISET TDM I AND PRECISET TDM II CALIBRATORS · Roche Diagnostics Corp. · Aug 6, 2003
- K033879 — VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 · Maine Standards Co. · Feb 27, 2004
Submission Summary (Full Text)
{0}
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k060429
B. Purpose for Submission:
Clearance of new device
C. Measurand:
Assayed controls for acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetyl procainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid and vancomycin.
D. Type of Test:
Not applicable.
E. Applicant:
Roche Diagnostics Corporation
F. Proprietary and Established Names:
TDM Control Set
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| Multi-Analyte Controls
(Assayed And Unassayed)
(JJY) | Class I | 21 CFR 862.1660,
Quality control
material (assayed and
unassayed). | 75 Clinical
Chemistry
(CH) |
H. Intended Use:
1. Intended use(s):
See Indications for Use below.
2. Indication(s) for use:
The TDM Control Set is intended for use as an assayed quality control product on Roche/Hitachi and COBAS INTEGRA analyzers. Three assayed levels of acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetyl procainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid and vancomycin are provided.
{1}
3. Special conditions for use statement(s):
For Prescription use only
4. Special instrument requirements:
Roche/Hitachi and COBAS Integra analyzers
I. Device Description:
The TDM Control Set is a human serum based liquid control with seventeen added therapeutic drugs, preservative and stabilizer. The drugs are acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid and vancomycin.
Each TDM Control Set contains 2 bottles of controls (a 5.0 ml fill volume per bottle) at Levels 1, II and III.
J. Substantial Equivalence Information:
1. Predicate device name(s):
CLINIQA Liquid QC TDM Controls Levels, 1, 2, & 3
2. Predicate 510(k) number(s):
k041898
3. Comparison with the Predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Assayed quality control material | Same |
| Levels | Three | Same |
| Matrix | Human serum based liquid | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Number of Constituents | Seventeen | Nineteen |
| Constituents | acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid and vancomycin. | acetaminophen, amikacin, carbamazepine, disopyramide, digoxin, ethosuximide, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, |
{2}
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Constituents | | theophylline, tobramycin, valproic acid and vancomycin. |
| Target Range | Different assigned values | Different assigned values |
## K. Standard/Guidance Document Referenced (if applicable):
1. ISO 14971:2000, Medical Devices – Application of risk management to medical devices.
2. FDA Guidance: Format for Traditional and Abbreviated 510(k)s.
3. FDA Guidance: Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; Draft.
4. FDA Guidance: Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices.
## L. Test Principle:
Not applicable.
## M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Roche Diagnostics maintains a set of master calibrators for each assay that have values assigned that are traceable to the various reference standards. The TDM Control Set products are assayed and traceable to USP standards. Values are assigned using the Hitachi 917, Module P and COBAS Integra 400/700/800 analyzers. A minimum of two independent series of analyses are performed on each instrument for each analyte. Each sample is tested in duplicate. The target value is then calculated as the median of the determined values. The following tables list lot-specific target values and ranges.
{3}
TDM Control Set
Lot 674373
Level 1
| Component | Method | Value | Range | Unit |
| --- | --- | --- | --- | --- |
| Acetaminophen | COBAS INTEGRA | 15.1 | 10.6 - 19.6 | μg/mL |
| | | 100.0 | 70.0 - 130.0 | μmol/L |
| | Roche/Hitachi Systems | 11.2 | 7.9 - 14.5 | μg/mL |
| | | 74.1 | 51.9 - 96.3 | μmol/L |
| Amikacin | COBAS INTEGRA | 5.33 | 4.25 - 6.41 | μg/mL |
| | | 9.11 | 7.28 - 10.94 | μmol/L |
| | ONLINE | 5.14 | 3.91 - 6.37 | μg/mL |
| | | 8.79 | 6.69 - 10.89 | μmol/L |
| Carbamazepine | COBAS INTEGRA | 3.30 | 2.64 - 3.96 | μg/mL |
| | | 14.0 | 11.3 - 16.7 | μmol/L |
| | CEDIA Roche/Hitachi | 3.30 | 2.52 - 4.08 | μg/mL |
| | | 14.0 | 10.7 - 17.3 | μmol/L |
| | ONLINE | 3.28 | 2.62 - 3.94 | μg/mL |
| | | 13.9 | 11.2 - 16.6 | μmol/L |
| Digoxin | COBAS INTEGRA | 0.750 | 0.450 - 1.050 | μg/mL |
| | | 0.960 | 0.576 - 1.344 | μmol/L |
| | Tina-quant Roche/Hitachi | 0.740 | 0.563 - 0.917 | μg/mL |
| | | 0.947 | 0.719 - 1.175 | μmol/L |
| | CEDIA Roche/Hitachi | 1.29 | 0.90 - 1.68 | μg/mL |
| | | 1.65 | 1.14 - 2.16 | μmol/L |
| Gentamicin | COBAS INTEGRA | 2.12 | 1.70 - 2.54 | μg/mL |
| | | 4.43 | 3.53 - 5.33 | μmol/L |
| | CEDIA Roche/Hitachi | 1.97 | 1.49 - 2.45 | μg/mL |
| | | 4.12 | 3.13 - 5.11 | μmol/L |
| | ONLINE | 2.07 | 1.65 - 2.49 | μg/mL |
| | | 4.33 | 3.46 - 5.20 | μmol/L |
| Lidocaine | COBAS INTEGRA | 1.46 | 1.16 - 1.76 | μg/mL |
| | | 6.23 | 4.97 - 7.49 | μmol/L |
| N-acetylprocainamide | COBAS INTEGRA | 3.96 | 3.18 - 4.74 | μg/mL |
| | | 14.3 | 11.3 - 17.3 | μmol/L |
| | CEDIA Roche/Hitachi | 3.87 | 2.94 - 4.80 | μg/mL |
| | | 14.0 | 10.7 - 17.3 | μmol/L |
| Phenobarbital | COBAS INTEGRA | 9.88 | 7.90 - 11.86 | μg/mL |
| | | 42.6 | 34.2 - 51.0 | μmol/L |
| | CEDIA Roche/Hitachi | 9.42 | 7.53 - 11.31 | μg/mL |
| | | 40.6 | 32.5 - 48.7 | μmol/L |
| Phenytoin | COBAS INTEGRA | 6.37 | 5.11 - 7.63 | μg/mL |
| | | 25.2 | 20.1 - 30.3 | μmol/L |
| | CEDIA Roche/Hitachi | 6.67 | 5.08 - 8.26 | μg/mL |
| | CEDIA Roche Hitachi | 26.4 | 20.1 - 32.7 | μmol/L |
| | ONLINE | 6.68 | 5.33 - 8.03 | μg/mL |
| | | 26.5 | 21.1 - 31.9 | μmol/L |
| Primidone | COBAS INTEGRA | 2.67 | 2.13 - 3.21 | μg/mL |
| | | 12.2 | 9.8 - 14.6 | μmol/L |
| Procainamide | COBAS INTEGRA | 1.76 | 1.40 - 2.12 | μg/mL |
| | | 7.44 | 5.94 - 8.94 | μmol/L |
| | CEDIA Roche/Hitachi | 1.66 | 1.27 - 2.05 | μg/mL |
| | | 7.02 | 5.34 - 8.70 | μmol/L |
{4}
TDM Control Set
Lot 674373
Level 1
| Component | Method | Value | Range | Unit |
| --- | --- | --- | --- | --- |
| Quinidine | COBAS INTEGRA | 1.06 | 0.85 - 1.27 | μg/mL |
| | | 3.26 | 2.60 - 3.92 | μmol/L |
| | ONLINE | 0.980 | 0.746 - 1.214 | μg/mL |
| | | 3.02 | 2.30 - 3.74 | μmol/L |
| Salicylate | COBAS INTEGRA | 43.1 | 34.4 - 51.8 | μg/mL |
| | | 0.312 | 0.249 - 0.375 | μmol/L |
| Theophylline | COBAS INTEGRA | 5.36 | 4.28 - 6.44 | μg/mL |
| | | 29.7 | 23.7 - 35.7 | μmol/L |
| | CEDIA Roche/Hitachi | 4.92 | 3.75 - 6.09 | μg/mL |
| | | 27.3 | 20.7 - 33.9 | μmol/L |
| | ONLINE | 5.38 | 4.30 - 6.46 | μg/mL |
| | | 29.9 | 23.9 - 35.9 | μmol/L |
| Tobramycin | COBAS INTEGRA | 1.55 | 1.25 - 1.85 | μg/mL |
| | | 3.32 | 2.66 - 3.98 | μmol/L |
| | CEDIA Roche/Hitachi | 2.21 | 1.61 - 2.81 | μg/mL |
| | | 4.73 | 3.44 - 6.02 | μmol/L |
| Valproic acid | COBAS INTEGRA | 36.2 | 29.0 - 43.4 | μg/mL |
| | | 251 | 200 - 302 | μmol/L |
| | CEDIA Roche/Hitachi | 40.8 | 30.9 - 50.7 | μg/mL |
| | | 283 | 214 - 352 | μmol/L |
| Vancomycin | COBAS INTEGRA | 6.87 | 5.49 - 8.25 | μg/mL |
| | | 4.74 | 3.78 - 5.70 | μmol/L |
TDM Control Set
Lot 674373
Level II
| Component | Method | Value | Range | Unit |
| --- | --- | --- | --- | --- |
| Acetaminophen | COBAS INTEGRA | 34.7 | 27.8 - 41.6 | μg/mL |
| | | 230 | 185 - 275 | μmol/L |
| | Roche/Hitachi Systems | 30.9 | 23.4 - 38.4 | μg/mL |
| | | 205 | 157 - 253 | μmol/L |
| Amikacin | COBAS INTEGRA | 14.2 | 11.5 - 16.9 | μg/mL |
| | | 24.3 | 19.5 - 29.1 | μmol/L |
| | ONLINE | 14.5 | 11.5 - 17.5 | μg/mL |
| | | 24.8 | 19.7 - 29.9 | μmol/L |
| Carbamazepine | COBAS INTEGRA | 9.51 | 7.62 - 11.40 | μg/mL |
| | | 40.2 | 32.1 - 48.3 | μmol/L |
| | CEDIA Roche/Hitachi | 9.30 | 7.08 - 11.52 | μg/mL |
| | | 39.3 | 30.0 - 48.6 | μmol/L |
| | ONLINE | 10.1 | 8.0 - 12.2 | μg/mL |
| | | 42.7 | 34.3 - 51.1 | μmol/L |
| Digoxin | COBAS INTEGRA | 1.72 | 1.39 - 2.05 | μg/mL |
| | | 2.20 | 1.75 - 2.65 | μmol/L |
| | Tina-quant | 1.80 | 1.38 - 2.22 | μg/mL |
| | Roche/Hitachi | 2.30 | 1.76 - 2.84 | μmol/L |
| | CEDIA Roche/Hitachi | 2.32 | 1.75 - 2.89 | μg/mL |
| | | 2.97 | 2.25 - 3.69 | μmol/L |
| Gentamicin | COBAS INTEGRA | 5.28 | 4.23 - 6.33 | μg/mL |
{5}
TDM Control Set
Lot 674373
Level II
| Component | Method | Value | Range | Unit |
| --- | --- | --- | --- | --- |
| Lidocaine | CEDIA Roche/Hitachi | 11.0 | 8.9 - 13.1 | μmol/L |
| | | 5.40 | 4.11 - 6.69 | μg/mL |
| | | 11.3 | 8.6 - 14.0 | μmol/L |
| | ONLINE | 5.43 | 4.35 - 6.51 | μg/mL |
| | | 11.3 | 8.9 - 13.7 | μmol/L |
| N-acetylprocainamide | COBAS INTEGRA | 4.26 | 3.42 - 5.10 | μg/mL |
| | | 18.2 | 14.6 - 21.8 | μmol/L |
| Phenobarbital | COBAS INTEGRA | 7.23 | 5.79 - 8.67 | μg/mL |
| | | 26.1 | 21.0 - 31.2 | μmol/L |
| | CEDIA Roche/Hitachi | 7.19 | 5.45 - 8.93 | μg/mL |
| | | 26.0 | 19.7 - 32.3 | μmol/L |
| Phenobarbital | COBAS INTEGRA | 23.1 | 18.6 - 27.6 | μg/mL |
| | | 99.6 | 79.8 - 119.4 | μmol/L |
| | CEDIA Roche/Hitachi | 23.3 | 18.5 - 28.1 | μg/mL |
| | | 100 | 79 - 121 | μmol/L |
| Phenytoin | COBAS INTEGRA | 12.3 | 9.9 - 14.7 | μg/mL |
| | | 48.7 | 39.1 - 58.3 | μmol/L |
| | CEDIA Roche/Hitachi | 13.3 | 10.0 - 16.6 | μg/mL |
| | | 52.7 | 40.1 - 65.3 | μmol/L |
| | ONLINE | 13.0 | 10.3 - 15.7 | μg/mL |
| | | 51.5 | 41.3 - 61.7 | μmol/L |
| Primidone | COBAS INTEGRA | 7.74 | 6.18 - 9.30 | μg/mL |
| | | 35.4 | 28.2 - 42.6 | μmol/L |
| Procainamide | COBAS INTEGRA | 7.30 | 5.83 - 8.77 | μg/mL |
| | | 30.9 | 24.6 - 37.2 | μmol/L |
| | CEDIA Roche/Hitachi | 7.04 | 5.36 - 8.72 | μg/mL |
| | | 29.8 | 22.6 - 37.0 | μmol/L |
| Quinidine | COBAS INTEGRA | 2.98 | 2.38 - 3.58 | μg/mL |
| | | 9.18 | 7.35- 11.01 | μmol/L |
| | ONLINE | 2.90 | 2.33 - 3.47 | μg/mL |
| | | 8.93 | 7.13 -10.73 | μmol/L |
| Salicylate | COBAS INTEGRA | 162 | 129 - 195 | μg/mL |
| | | 1.17 | 0.93 - 1.41 | μmol/L |
| Theophylline | COBAS INTEGRA | 14.7 | 11.7 - 17.7 | μg/mL |
| | | 81.6 | 65.4 - 97.8 | μmol/L |
| | CEDIA Roche/Hitachi | 14.1 | 10.8 - 17.4 | μg/mL |
| | | 78.3 | 59.4 - 97.2 | μmol/L |
| | ONLINE | 14.6 | 11.6 - 17.6 | μg/mL |
| | | 81.0 | 64.8 - 97.2 | μmol/L |
| Tobramycin | COBAS INTEGRA | 3.62 | 2.90 - 4.34 | μg/mL |
| | | 7.75 | 6.19 - 9.31 | μmol/L |
| | CEDIA Roche/Hitachi | 4.86 | 3.54 - 6.18 | μg/mL |
| | | 10.4 | 7.7 - 13.1 | μmol/L |
| Valproic acid | COBAS INTEGRA | 76.9 | 61.6 - 92.2 | μg/mL |
| | | 533 | 425 - 641 | μmol/L |
| | CEDIA Roche/Hitachi | 85.2 | 64.8- 105.6 | μg/mL |
| | | 590 | 449 - 731 | μmol/L |
| Vancomycin | COBAS INTEGRA | 22.3 | 17.8 - 26.8 | μg/mL |
{6}
TDM Control Set
Lot 674373
Level II
| Component | Method | Value | Range | Unit |
| --- | --- | --- | --- | --- |
| | | 15.4 | 12.4 - 18.4 | μmol/L |
TDM Control Set
Lot 674373
Level III
| Component | Method | Value | Range | Unit |
| --- | --- | --- | --- | --- |
| Acetaminophen | COBAS INTEGRA | 109 | 88 - 130 | μg/mL |
| | | 722 | 578 - 866 | μmol/L |
| | Roche/Hitachi Systems | 105 | 81 - 129 | μg/mL |
| | | 695 | 527 - 863 | μmol/L |
| Amikacin | COBAS INTEGRA | 26.4 | 21.0 - 31.8 | μg/mL |
| | | 45.1 | 36.1 - 54.1 | μmol/L |
| | ONLINE | 29.8 | 23.8 - 35.8 | μg/mL |
| | | 51.0 | 40.8 - 61.2 | μmol/L |
| Carbamazepine | COBAS INTEGRA | 15.6 | 12.6 - 18.6 | μg/mL |
| | | 66.0 | 52.8 - 79.2 | μmol/L |
| | CEDIA Roche/Hitachi | 14.8 | 11.2 - 18.4 | μg/mL |
| | | 62.6 | 47.6 - 77.6 | μmol/L |
| | ONLINE | 15.6 | 12.6 - 18.6 | μg/mL |
| | | 66.0 | 52.8 - 79.2 | μmol/L |
| Digoxin | COBAS INTEGRA | 3.48 | 2.10 - 4.86 | μg/mL |
| | | 4.45 | 2.68 - 6.22 | μmol/L |
| | Tina-quant Roche/Hitachi | 3.54 | 2.70 - 4.38 | μg/mL |
| | | 4.53 | 3.45 - 5.61 | μmol/L |
| | CEDIA Roche/Hitachi | 3.95 | 2.99 - 4.91 | μg/mL |
| | | 5.06 | 3.86 - 6.26 | μmol/L |
| Gentamicin | COBAS INTEGRA | 8.07 | 6.45 - 9.69 | μg/mL |
| | | 16.9 | 13.6 - 20.2 | μmol/L |
| | CEDIA Roche/Hitachi | 8.31 | 6.06 - 10.56 | μg/mL |
| | | 17.4 | 12.6 - 22.2 | μmol/L |
| | ONLINE | 8.31 | 6.66 - 9.96 | μg/mL |
| | | 17.4 | 13.8 - 21.0 | μmol/L |
| Lidocaine | COBAS INTEGRA | 6.46 | 5.17 - 7.75 | μg/mL |
| | | 27.6 | 22.2 - 33.0 | μmol/L |
| N-acetylprocainamide | COBAS INTEGRA | 12.1 | 9.7 - 14.5 | μg/mL |
| | | 43.7 | 35.0 - 52.4 | μmol/L |
| | CEDIA Roche/Hitachi | 12.7 | 9.7 - 15.7 | μg/mL |
| | | 45.8 | 34.7 - 56.9 | μmol/L |
| Phenobarbital | COBAS INTEGRA | 42.8 | 34.1 - 51.5 | μg/mL |
| | | 184 | 148 - 220 | μmol/L |
| | CEDIA Roche/Hitachi | 45.3 | 36.3 - 54.3 | μg/mL |
| | | 195 | 156 - 234 | μmol/L |
| Phenytoin | COBAS INTEGRA | 22.1 | 17.6 - 26.6 | μg/mL |
| | | 87.5 | 70.1 - 104.9 | μmol/L |
| | CEDIA Roche/Hitachi | 24.0 | 18.3 - 29.7 | μg/mL |
| | | 95.0 | 72.2 - 117.8 | μmol/L |
| | ONLINE | 22.8 | 18.3 - 27.3 | μg/mL |
| | | 90.3 | 72.3 - 108.3 | μmol/L |
| Primidone | COBAS INTEGRA | 16.1 | 12.8 - 19.4 | μg/mL |
| | | 73.7 | 59.0 - 88.4 | μmol/L |
{7}
TDM Control Set
Lot 674373
Level III
| Component | Method | Value | Range | Unit |
| --- | --- | --- | --- | --- |
| Procainamide | COBAS INTEGRA | 11.5 | 9.1 - 13.9 | μg/mL |
| | | 48.6 | 39.0 - 58.2 | μmol/L |
| | CEDIA Roche/Hitachi | 10.6 | 8.2 - 13.0 | μg/mL |
| | | 44.8 | 34.0 - 55.6 | μmol/L |
| Quinidine | COBAS INTEGRA | 4.78 | 3.82 - 5.74 | μg/mL |
| | | 14.7 | 11.7 - 17.7 | μmol/L |
| | ONLINE | 4.59 | 3.66 - 5.52 | μg/mL |
| | | 14.1 | 11.4 - 16.8 | μmol/L |
| Salicylate | COBAS INTEGRA | 442 | 355 - 529 | μg/mL |
| | | 3.20 | 2.57 - 3.83 | μmol/L |
| Theophylline | COBAS INTEGRA | 29.5 | 23.5 - 35.5 | μg/mL |
| | | 164 | 131 - 197 | μmol/L |
| | CEDIA Roche/Hitachi | 28.5 | 21.6 - 35.4 | μg/mL |
| | | 158 | 119 - 197 | μmol/L |
| | ONLINE | 29.6 | 23.6 - 35.6 | μg/mL |
| | | 164 | 131 - 197 | μmol/L |
| Tobramycin | COBAS INTEGRA | 7.68 | 6.15 - 9.21 | μg/mL |
| | | 16.4 | 13.1 - 19.7 | μmol/L |
| | CEDIA Roche/Hitachi | 9.82 | 7.18 - 12.46 | μg/mL |
| | | 21.0 | 15.3 - 26.7 | μmol/L |
| Valproic acid | COBAS INTEGRA | 122 | 98 - 146 | μg/mL |
| | COBAS INTEGRA | 845 | 677 - 1.013 | μmol/L |
| | CEDIA Roche/Hitachi | 132 | 96 - 168 | μg/mL |
| | | 915 | 669 - 1.161 | μmol/L |
| Vancomycin | COBAS INTEGRA | 35.2 | 28.3 - 42.1 | μg/mL |
| | | 24.3 | 19.5 - 29.1 | μmol/L |
The sponsor performed the following studies to verify the stability claims for the TDM Control Set.
| Stability | Unopened | Opened |
| --- | --- | --- |
| TDM Control Set | Store at 2 - 8°C until expiration date | 12 months at 2–8°C. |
Unopened: The TDM Control Set products were stored at 45°C for 10 days, 37°C every other day for 20 days, 32°C every third day for 30 days for a total of ten bottles per level. Each vial was assayed in triplicate using the Integra 400 and compared to the reference that was initially stored at-70°C. The product met the sponsor's acceptance criterion (95-105% of the reference). The sponsor is continuing real-time stability studies using the COBAS Integra TDM Assays on the Integra 400 or 700 analyzers.
Opened: The TDM Control Set products were sampled frequently over 120 days. Vials were tested every 30 days and compared to newly opened vials of TDM Control
{8}
Set products. The product met the sponsor’s acceptance criterion (recovery at ±5% of the newly opened vials.) The sponsor is continuing opened vial real-time stability studies.
d. Detection limit:
Not applicable
e. Analytical specificity:
Not applicable
f. Assay cut-off:
Not applicable
2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:
Not applicable
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Not applicable
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
