(366 days)
Not Found
Not Found
No
The summary describes a quantitative assay for phenytoin concentration using a standard laboratory analyzer and does not mention any AI or ML components.
No
The device is an in vitro diagnostic (IVD) tool used to measure phenytoin levels in human serum, which aids in diagnosis and treatment monitoring, but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that Phenytoin is "intended for in vitro diagnostic use" and that "Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to help ensure proper therapy."
No
The device is an in vitro diagnostic assay and calibrator used on a specific analyzer (T60). This involves chemical reagents and hardware (the analyzer), not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "Phenytoin is intended for in vitro diagnostic use..."
- "TDM Calibration set B is intended for in vitro diagnostic use..."
This clearly indicates that the device is designed to be used outside of the body to examine specimens (in this case, human serum) for diagnostic purposes.
N/A
Intended Use / Indications for Use
Phenytoin
For in vitro diagnostic use in the quantitative determination of the phenytoin concentration in human serum on T60 analyzer. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin 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 981647 Phenytoin assay on T60 Analyzer
Phenytoin is intended for quantitative in-vitro diagnostic determination of the phenytoin concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to help ensure proper therapy.
For TDM Calibration set B, see intended use.
Product codes (comma separated list FDA assigned to the subject device)
DIP, DKB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of precision for the new device (#1) versus the predicate device (#1) is provided.
Precision
New device #1
Within run
Level 8.6 µg/ml
SD = 0.20
CV(%) = 2.4
Level 20.0 µg/ml
SD = 0.32
CV(%) = 1.6
Between run
Level 8.6 µg/ml
SD = 0.15
CV(%) = 1.7
Level 20.0 µg/ml
SD = 0.23
CV(%) = 1.2
Total
Level 8.6 µg/ml
SD = 0.39
CV(%) = 4.5
Level 20.0 µg/ml
SD = 0.59
CV(%) = 3.0
Predicate device #1
Within run
Level 6.3 µg/ml
SD = 0.20
CV(%) = 3.2
Level 14.8 µg/ml
SD = 0.29
CV(%) = 2.0
Level 26.8 µg/ml
SD = 0.35
CV(%) = 1.3
Total
Level 6.3 µg/ml
SD = 0.32
CV(%) = 5.1
Level 14.8 µg/ml
SD = 0.46
CV(%) = 3.1
Level 26.8 µg/ml
SD = 0.60
CV(%) = 2.3
Method Comparison
New device #1
(Unit µg/ml)
(Deming):
y = 1.00x - 0.8
r = 0.995
Range 1.3 - 38.3 µg/ml
N = 70
Predicate device #1
Previous CEDIA® Phenytoin assay (x). Correlation (µg/ml)
(Deming's):
Y=1.00x -0.19
r = 0.998
Sy.x = 0.39
Range 0.7 - 35.1 µg/ml
N = 114
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See summary of performance studies for precision values.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The CEDIA® Phenytoin II
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3350 Diphenylhydantoin test system.
(a)
Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.(b)
Classification. Class II.
0
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: K063145
A. Introduction:
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: Phenytoin Common name: Phenytoin Test System Classification: II Class: Toxicology Product Code: DIP
Proprietary name: TDM Calibration set B Common name: Calibrator Classification: II Toxicology Class: Product Code: DKB
Thermo Fisher Scientific Oy
Ratastic 2 P.O. Box 100 FIN-01621 Vantaa Finland
- 358 (9) 329 100 tel
Y-tunnus 0921547-0 AT No FI09215470 Domicile Helsinki
s w.themo.com
1
D. Intended Use
Phenytoin
For in vitro diagnostic use in the quantitative determination of the phenytoin concentration in human serum on T60 analyzer. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin 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 981647 Phenytoin assay on T60 Analyzer
Thermo Fisher Scientific Oy
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 F109215470 Domicile Helsinki
2
E. Indications for use
Phenytoin is intended for quantitative in-vitro diagnostic determination of the phenytoin concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to help ensure proper therapy.
For TDM Calibration set B, see intended use.
F. Substantial Equivalence
Microgenics Corporation item: The CEDIA® Phenytoin II
G. Substantial equivalence -similarities
Phenytoin is substantially equivalent to other devices legally marketed in United States. We claim equivalence to the Microgenics Corporation item, the CEDIA® Phenytoin II
Thermo Fisher Scientific Oy
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
3
H. The following table compares the Phenytoin with the predicate assay
Table 1
| Phenytoin | ||
|---|---|---|
| Attribute | New device #1 | Predicate device #1 |
| Intended Use | For in vitro diagnostic use in the | |
| quantitative determination of the | ||
| phenytoin concentration in human | ||
| serum on T60 analyzer. | ||
| Measurements are used in the | ||
| diagnosis and treatment of phenytoin | ||
| overdose and in monitoring levels of | ||
| phenytoin to help ensure proper | ||
| therapy | The CEDIA® Phenytoin II | |
| homogeneous enzyme immunoassay | ||
| is for the quantitation of phenytoin | ||
| in human serum or plasma using | ||
| automated clinical chemistry | ||
| analyzers. Measurements are used in | ||
| the diagnosis and treatment of | ||
| phenytoin overdose and in | ||
| monitoring levels of phenytoin to | ||
| ensure proper therapy. | ||
| Indication for Use | Phenytoin is intended for quantitative | |
| in-vitro diagnostic determination of | ||
| the phenytoin concentration in | ||
| human serum using T60 Clinical | ||
| Chemistry Analyzers. Measurements | ||
| are used in the diagnosis and | ||
| treatment of phenytoin overdose and | ||
| in monitoring levels of phenytoin to | ||
| help ensure proper therapy. | See Intended Use | |
| Assay Protocol | Assay uses recombinant DNA | |
| technology (US Patent no. 4708929) | ||
| to produce a unique homogeneous | ||
| enzyme immunoassay system. | Assay uses recombinant DNA | |
| technology (US Patent no. 4708929) | ||
| to produce a unique homogeneous | ||
| enzyme immunoassay system. | ||
| Traceability/Standardization | The calibration values are traceable | |
| to USP reference materials prepared | ||
| gravimetrically to drug-free human | ||
| serum. | ||
| Sample Type | Serum | Serum or plasma (Na or Li heparin, |
| Na EDTA) | ||
| Reagent Storage | The unopened reagents are stable at | |
| 2...8 °C until the expiration date | ||
| stated on the label. Refer to the | ||
| Application Notes of your T60 | ||
| analyzer for the on board stability | ||
| of reagents. | ||
| DO NOT FREEZE the unopened | ||
| reagents or the reconstituted | ||
| reagents. | Store CEDIA® Phenytoin II | |
| reagents at 2-8 °C. Do not freeze. | ||
| For stability of the unopened | ||
| components refer to the box or | ||
| bottle labels for the expiration date | ||
| Attribute | New device #1 | Predicate device #1 |
| Expected Values | Therapeutic range for adults: | |
| 10 - 20 µg/ml or | ||
| 40 - 79 µmol/l (1,2) | Therapeutic range: | |
| 10 - 20 µg/ml for adults | ||
| 6 - 14 µg/ml for children | ||
| Instrument | T60 and DPC T60i, DPC T60i Kusti | Roche Hitachi 912 |
| Measuring Range | 0.8 - 38 µg/ml (3.2 – 150 µmol/l) | Between 0.6 µg/ml and the value of |
| the Core TDM Multi-Cal High | ||
| Calibrator (approximately 40 µg/ml | ||
| or 158.4 µmol/l) | ||
| Precision | Within run | |
| Level 8.6 µg/ml | ||
| SD = 0.20 | ||
| CV(%) = 2.4 | ||
| Level 20.0 µg/ml | ||
| SD = 0.32 | ||
| CV(%) = 1.6 | ||
| Between run | ||
| Level 8.6 µg/ml | ||
| SD = 0.15 | ||
| CV(%) = 1.7 | ||
| Level 20.0 µg/ml | ||
| SD = 0.23 | ||
| CV(%) = 1.2 | ||
| Total | ||
| Level 8.6 µg/ml | ||
| SD = 0.39 | ||
| CV(%) = 4.5 | ||
| Level 20.0 µg/ml | ||
| SD = 0.59 | ||
| CV(%) = 3.0 | Within run | |
| Level 6.3 µg/ml | ||
| SD = 0.20 | ||
| CV(%) = 3.2 | ||
| Level 14.8 µg/ml | ||
| SD = 0.29 | ||
| CV(%) = 2.0 | ||
| Level 26.8 µg/ml | ||
| SD = 0.35 | ||
| CV(%) = 1.3 | ||
| Total | ||
| Level 6.3 µg/ml | ||
| SD = 0.32 | ||
| CV(%) = 5.1 | ||
| Level 14.8 µg/ml | ||
| SD = 0.46 | ||
| CV(%) = 3.1 | ||
| Level 26.8 µg/ml | ||
| SD = 0.60 | ||
| CV(%) = 2.3 | ||
| Method Comparison | (Unit µg/ml) | |
| (Deming): | ||
| $y = 1.00x - 0.8$ | ||
| r = 0.995 | ||
| Range 1.3 - 38.3 µg/ml | ||
| N = 70 | Previous CEDIA® Phenytoin | |
| assay (x). Correlation (µg/ml) | ||
| (Deming's): | ||
| $Y=1.00x -0.19$ | ||
| r = 0.998 | ||
| Sy.x = 0.39 | ||
| Range 0.7 - 35.1 µg/ml | ||
| N = 114 | ||
| Attribute | New device #1 | Predicate device #1 |
| Limitations | No interference found | |
| Bilirubin: | ||
| up to 58 mg/dl (1000 $\mu$ mol/l) |
Hemoglobin:
up to 1000 mg/dl (10 g/l)
Lipemia:
up to 1000 mg/dl (10 g/l) of
Intralipid® | Ikterus:
No significant interference from
bilirubin up to I index of 60
(approximate bilirubin
concentration: 60 mg/dl)
Hemolysis:
No significant interference from
hemoglobin up to H index of 1000
(approximate hemoglobin
concentration: 1000 mg/dl)
Lipemia (Intralipid®):
No significant interference from
lipemia up to L index of 1000
(approximate triglycerides
concentration: 2000 mg/dl).
No significant interference from
total protein up to 12 g/dl.
No significant interference from
rheumatoid factor up to 100 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
4
Thermo Fisher Scientific Oy
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
ww.thermo.com
5
nermori SCIENTIFI
:
Thermo Fisher Scientific Oy
Ratastie 2
P.C). Box 100
FIN-01621 Vantaa
Finland
+358 (9) 329 100 tel +358 (9) 3291 0500 fax Y-tunnus 0921 547-0
VAT No FI09215470 Domicile Helsinki
6_Ver08
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Thermo Fisher Scientific Oy c/o Paivi Sormunen Ratastie 2 P.O. Box 100 FIN-01621 Vantaa Finland
OCT 1 7 2007
K063145 Re: Trade/Device Name: Phentoin, TDM Calibration Set B Regulation Number: 21 CFR 862.3350 Regulation Name: Diphenylhydantoin test system Regulatory Class: Class II Product Code: DIP, DKB Dated: September 25, 2007 Received: September 27, 2007
Dear Ms. 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).
7
Page 2 -
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. Cooper, M.S., D.v.M.
Jean 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
8
Indications for Use
510(k) Number (if known): K063145
Device Names: Phenytoin TDM Calibration set B
Indications for Use:
Phenytoin is intended for quantitative in vitro diagnostic determination of the phenytoin concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin 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 981647 Phenytoin assay on T60 Analyzer.
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 Diagnostic Device Evaluation and Safety (OIVD)
Signature of CBID, SI
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K063145