(154 days)
Not Found
No
The summary describes a quantitative in vitro diagnostic assay for measuring complement proteins on a clinical chemistry analyzer. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on method comparison and precision, which are standard for IVD assays and do not suggest the use of AI/ML.
No
This device is for in vitro diagnostic use, specifically for quantitative determination of complement C3 and C4 in human serum, which aids in diagnosis of immunologic disorders, not treatment.
Yes
The "Intended Use / Indications for Use" states that the device is for "in vitro diagnostic use" and that C3 and C4 measurements "may aid in the diagnosis of immunologic disorders."
No
The device is an in vitro diagnostic (IVD) assay intended for use on a specific hardware analyzer (T60). The summary describes the performance of the assay itself, not a standalone software application.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "For in vitro diagnostic use in the quantitative determination of the complement C3 concentration in human serum on the T60 analyzer."
- "For in vitro diagnostic use in the quantitative determination of the complement C4 concentration in human serum on the T60 analyzer."
- "The complement C3 and complement C4 are intended for quantative in-vitro diagnostic determination of the complement C3 and C4 concentration in human serum using T60 Clinical Chemistry Analyzers."
These statements clearly indicate that the device is intended to be used outside of the body (in vitro) to diagnose or aid in the diagnosis of conditions by analyzing human samples (serum). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative determination of the complement C3 concentration in human serum on the T60 analyzer.
For in vitro diagnostic use in the quantitative determination of the complement C4 concentration in human serum on the T60 analyzer.
For in vitro diagnostic use on T60 analyzer. SpeciCal protein calibrator is used as a stock calibrator for both quantification of specific proteins in serum and plasma by immunoturbidimetry and for antigen excess detection using methods defined by Thermo Electron Oy.
For in vitro diagnostic use on T60 analyzer. SpeciTrol is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy.
For in vitro diagnostic use on T60 analyzer. Specitrol High is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy.
The complement C3 and complement C4 are intended for quantative in-vitro diagnostic determination of the complement C3 and C4 concentration in human serum using T60 Clinical Chemistry Analyzers. C3 and C4 measurements may aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
Product codes (comma separated list FDA assigned to the subject device)
CZW, DBI, JIX, JJY
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)
Method Comparison (Complement C3): y = 0.98x + 4.99, R = 0.989, Range 28 to 299 mg/dL, N = 102
Method Comparison (Complement C4): y = 0.99x – 0.18, R = 0.995, Range 3 to 88 mg/dl, N = 88
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision (Complement C3):
Within run:
Level 33 mg/dL, SD = 0.5, CV% = 1.4
Level 42 mg/dL, SD = 0.6, CV% = 1.3
Level 89 mg/dL, SD = 0.7, CV(%) = 0.8
Level 216 mg/dL, SD = 2.0, CV(%) = 0.9
Level 406 mg/dL, SD = 3.4, CV% = 0.8
Level 441 mg/dL, SD = 2.4, CV% = 0.5
Between run:
Level 33 mg/dL, SD = 0.4, CV% = 1.2
Level 42 mg/dL, SD = 0.6, CV% = 1.5
Level 89 mg/dL, SD = 0.9, CV(%) = 1.0
Level 216 mg/dL, SD = 1.2, CV(%) = 0.6
Level 406 mg/dL, SD = 4.3, CV% = 1.1
Level 441 mg/dL, SD = 5.2, CV% = 1.2
Total:
Level 33 mg/dL, SD = 1.2, CV% = 3.7
Level 42 mg/dL, SD = 1.3, CV% = 3.0
Level 89 mg/dL, SD = 2.1, CV(%) = 2.3
Level 216 mg/dL, SD = 5.3, CV(%) = 2.4
Level 406 mg/dL, SD = 7.4, CV% = 1.8
Level 441 mg/dL, SD = 9.0, CV% = 2.0
Precision (Complement C4):
Within run:
Level 8 mg/dL, SD = 0.1, CV(%) = 1.3
Level 8 mg/dL, SD = 0.1, CV(%) = 1.5
Level 16 mg/dL, SD = 0.3, CV(%) = 1.7
Level 46 mg/dL, SD = 1.0, CV(%) = 2.2
Level 78 mg/dL, SD = 0.8, CV(%) = 1.0
Level 88 mg/dL, SD = 0.7, CV(%) = 0.8
Between run:
Level 8 mg/dL, SD = 0.1, CV(%) = 1.6
Level 8 mg/dL, SD = 0.1, CV(%) = 1.6
Level 16 mg/dL, SD = 0.3, CV(%) = 1.5
Level 46 mg/dL, SD = 0.9, CV(%) = 1.9
Level 78 mg/dL, SD = 0.6, CV(%) = 0.7
Level 88 mg/dL, SD = 0.7, CV(%) = 0.8
Total:
Level 8 mg/dL, SD = 0.2, CV(%) = 2.8
Level 8 mg/dL, SD = 0.2, CV(%) = 2.7
Level 16 mg/dL, SD = 0.6, CV(%) = 3.5
Level 46 mg/dL, SD = 2.0, CV(%) = 4.4
Level 78 mg/dL, SD = 1.4, CV(%) = 1.7
Level 88 mg/dL, SD = 1.5, CV(%) = 1.7
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.
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
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).
0
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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: K063150
A. Introduction:
According to the requirements of 21 CFR 807.92, the following information provides sufficent detail to understand the basis for a determination of substantial equivalence.
B. Submitter name
Thermo Electron Oy
C. Device name
Proprietary name: Complement C3 Common name: Complement C3 Classification: II Class: Immunology Product Code: CZW
Proprietary name: Complement C4 Complement C4 Common name: Classification: ] [ Class: Immunology Product Code: CZW
D. Intended Use
For in vitro diagnostic use in the quantitative determination of the complement C3 concentration in human serum on the T60 analyzer.
For in vitro diagnostic use in the quantitative determination of the complement C4 concentration in human serum on the T60 analyzer.
SpeciCal
For in vitro diagnostic use on T60 analyzer. SpeciCal protein calibrator is used as a stock calibrator for both quantification of specific proteins in serum and plasma by immunoturbidimetry and for antigen excess detection using methods defined by Thermo Electron Oy.
SpeciTrol
For in vitro diagnostic use on T60 analyzer. SpeciTrol is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy.
Thermo Electron Ov
Pro Box 100 FIN-01621 Vantaa Finland
+358 (9) 329 100 tel
+358 (9) 3291 0500 fax
/ - lunnus 0971547-0 VAT No RINQ215470 Domicile Relsinki
55 55 11:11:11:11:11 .11*1
1
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Specitrol High
For in vitro diagnostic use on T60 analyzer. Specitrol High is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy.
E. Indications for use
The complement C3 and complement C4 are intended for quantative in-vitro diagnostic determination of the complement C3 and C4 concentration in human serum using T60 Clinical Chemistry Analyzers. C3 and C4 measurements may aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
F. Substantial Equivalence
Bayer Corporation items: Bayer Clinical Method for ADVIA 1650 Complement C3 (C3) Bayer Clinical Method for ADVIA 1650 Complement C4 (C4)
Predicate device for the Specical calibrator: Liquid Specific Protein Calibrator, Bayer USA, K033791.
Predicate devices for the Specitrol and Specitrol High controls: Liquid Assayed Immunology Controls 1 and 3, Medical Analysis Systems USA, K960824.
G. Substantial equivalence -similarities
Complement C3 is substantially equivalent to other devices legally marketed in United States. We claim equivalence to the Bayer Clinical Method for ADVIA 1650 Complement C3 (C3)
Complement C4 is substantially equivalent to other devices legally marketed in United States. We claim equivalence to the Bayer Clinical Method for ADVIA 1650 Complement C4 (C4)
Specical is substantially equivalent to other devices legally marketed in United States. We claim equivalence to the Bayer Liguid Specific Protein Calibrator.
Specitrol and Specitrol High are substantially equivalent to other devices legally marketed in United States. We claim equivalence to the Medical Analysis Systems Liquid Assayed Immunology Controls 1 and 3.
Thermo Electron Ov
+358 (9) 329 100 tel +358 (9) 3291 0500 fax
Y-tunnus 0921547-0 VAT No F109715470 Domicile Helsinki
DE BOLD BER
2
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The following tables (Table 1 and Table 2) summarize comparative features of both test systems.
| Attribute | New device #1 | Predicate device #1 |
|---|---|---|
| Intented Use | For in vitro diagnostic use in the | |
| quantitative determination of the | ||
| complement C3 concentration in | ||
| human serum on the T60 | ||
| analyzer. | This in vitro diagnostic assay is | |
| intended to measure the | ||
| concentration of complement C3 | ||
| in human serum on an ADVIA® | ||
| Chemistry System. | ||
| Measurement of Complement | ||
| C3 levels is important in the | ||
| determination of inherited or | ||
| acquired deficiencies as well as | ||
| the diagnosis of inflammatory | ||
| and necrotic disorders. | ||
| Indication for Use | The complement C3 and | |
| complement C4 are intended for | ||
| quantative in-vitro diagnostic | ||
| determination of the complement | ||
| C3 and C4 concentration in | ||
| human serum using T60 Clinical | ||
| Chemistry Analyzers. C3 and C4 | ||
| measurements may aid in the | ||
| diagnosis of immunologic | ||
| disorders, especially those | ||
| associated with deficiencies of | ||
| complement components. | See intended use. | |
| Assay Protocol | PEG enhanced | |
| immunoturbidimetric. | PEG enhanced | |
| immunoturbidimetric. | ||
| Traceability/Standardi | ||
| zation | The value of Complement C3 has | |
| been assigned by using IFCC | ||
| preparate CRM 470 as a primary | ||
| reference. | IRMM reference Material CRM | |
| 470 from IFCC was evaluated | ||
| and found to recover 97% of | ||
| target concentration. | ||
| Sample Type | Human serum | Human serum. |
| Reagent Storage | Reagents in unopened vials are | |
| stable at 2...8 °C until the | ||
| expiration date printed on the | ||
| label. | Unopened reagents are stable | |
| until the expiration date printed | ||
| on the product label when stored | ||
| at 2°C - 8°C and protected from | ||
| light. |
Table 1 Complement C3
+358 (9) 329 100 tcl
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Y-tunnus 0921547-0
VAT No FI09215470
Domicile Holsinki
a sex the new call
3
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| Expected Values | 90 – 180 mg/dL | Healthy adults: | |
|---|---|---|---|
| 20 years 82-160 mg/dL | |||
| 30 years 84-160 mg/dL | |||
| 40 -70 years 90-170 mg/dL | |||
| Newborns 58-108 mg/dL | |||
| Children: | |||
| 3 months 67-124 mg/dL | |||
| 6 months 74-138 mg/dL | |||
| 9 months 78-144 mg/dL | |||
| 12 months 80-150 mg/dL | |||
| 2-10 years 80-150 mg/dL | |||
| 12-18 years 85-160 mg/dL | |||
| Instrument | T60i, T60i Kusti | ADVIA® 1650 Chemistry system. | |
| Measuring Range | 28* – 513 mg/d* | ||
| (* The values are related to the | |||
| Complement C3 concentration of | |||
| the calibrator and are lot | |||
| dependent.) | 0.46 mg/dL to the C3 | ||
| concentration in the Liquid | |||
| Specific Protein Calibrator | |||
| Level 6. | |||
| Precision | Within run | Within run | |
| Level 33 mg/dL | Level 64.02 mg/dL | ||
| SD = 0.5 | SD = 0.76 | ||
| CV% = 1.4 | CV(%) = 1.2 | ||
| Level 42 mg/dL | Level 124.13 mg/dL | ||
| SD = 0.6 | SD = 2.56 | ||
| CV% = 1.3 | CV(%) = 2.1 | ||
| Level 89 mg/dL | Level 182.35 mg/dL | ||
| SD = 0.7 | SD = 3.85 | ||
| CV(%) = 0.8 | CV(%) = 2.1 | ||
| Level 216 mg/dL | |||
| SD = 2.0 | Total | ||
| CV(%) = 0.9 | Level 64.02 mg/dL | ||
| Level 406 mg/dL | SD = 4.16 | ||
| SD = 3.4 | CV(%) = 6.5 | ||
| CV% = 0.8 | Level 124.13 mg/dL | ||
| Level 441 mg/dL | SD = 8.74 | ||
| SD = 2.4 | CV(%) = 7.0 | ||
| CV% = 0.5 | Level 182.35 mg/dL | ||
| Between run | SD = 12.16 | ||
| Level 33 mg/dL | CV(%) = 6.7 | ||
| SD = 0.4 | |||
| CV% = 1.2 | |||
| Level 42 mg/dL | |||
| SD = 0.6 | |||
| CV% = 1.5 | |||
| Level 89 mg/dL | |||
| SD = 0.9 | |||
| CV(%) = 1.0 | |||
| Level 216 mg/dL | |||
| SD = 1.2 | |||
| CV(%) = 0.6 | |||
| Level 406 mg/dL | |||
| SD = 4.3 | |||
| CV% = 1.1 | |||
| Level 441 mg/dL | |||
| SD = 5.2 | |||
| CV% = 1.2 | |||
| Total | |||
| Level 33 mg/dL | |||
| SD = 1.2 | |||
| CV% = 3.7 | |||
| Level 42 mg/dL | |||
| SD = 1.3 | |||
| CV% = 3.0 | |||
| Level 89 mg/dL | |||
| SD = 2.1 | |||
| CV(%) = 2.3 | |||
| Level 216 mg/dL | |||
| SD = 5.3 | |||
| CV(%) = 2.4 | |||
| Level 406 mg/dL | |||
| SD = 7.4 | |||
| CV% = 1.8 | |||
| Level 441 mg/dL | |||
| SD = 9.0 | |||
| CV% = 2.0 | |||
| Method Comparison | y = 0.98x + 4.99 | ||
| R = 0.989 | |||
| Range 28 to 299 mg/dL | |||
| N = 102 | Bayer RA Complement C3 | ||
| reagent run on ADVIA 1650 | |||
| Serum Y = 1.06x-6.47 | |||
| r = 0.952 | |||
| N = 40 | |||
| Sample Range | |||
| 44.6 - 250.6 mg/dL |
4
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.
Thermo Electron Oy
Ratastic 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
5
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| Limitations | Lipemia: | The following interferences
were tested up to the indicated
levels and found not to interfere. |
|-------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| | No interference found up to 500
mg/dL (5 g/l) of Intralipid. | Bilirubin (conjugated) $\leq$ 25 mg/dL |
| | Hemolysate:
No interference found up to 1000
mg/dl (10 g/l) of hemoglobin. | Bilirubin (unconjugated) $\leq$ 18.75 mg/dL |
| | Bilirubin, conjugated:
No interference found up to 58
mg/dL (1000 µmol/l) of
conjugated bilirubin. | Hemoglobin $\leq$ 1000 mg/dL |
| | Bilirubin, unconjugated:
No interference found up to 58
mg/dl (1000 µmol/l) of
unconjugated bilirubin. | Triglyceride (concentrate) $\leq$ 1000 mg/dL |
Thermo Electron Oy
:
:
Ratastic 2
P.O. Box 100
FIN-01621 Vantaa
Finland Finland
+358 (9) 329 100 tcl
+358 (9) 3291 0500 fax
Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki
6
| Table 2 Complement C4
| Attribute | New device #1 | Predicate device #1 |
|---|---|---|
| Intended Use | For in vitro diagnostic use in the | |
| quantitative determination of the | ||
| complement C4 concentration in | ||
| human serum on the T60 | ||
| analyzer. | This in vitro diagnostic assay is | |
| intended to measure the | ||
| concentration of complement C4 | ||
| in human serum on an ADVIA® | ||
| Chemistry System. | ||
| Measurement of Complement | ||
| C4 levels is important in the | ||
| determination of inherited or | ||
| acquired deficiencies as well as | ||
| the diagnosis of inflammatory | ||
| and necrotic disorders. | ||
| Indication for Use | The complement C3 and | |
| complement C4 are intended for | ||
| quantative in-vitro diagnostic | ||
| determination of the complement | ||
| C3 and C4 concentration in | ||
| human serum using T60 Clinical | ||
| Chemistry Analyzers. C3 and C4 | ||
| measurements may aid in the | ||
| diagnosis of immunologic | ||
| disorders, especially those | ||
| associated with deficiencies of | ||
| complement components. | See intended use | |
| Assay Protocol | PEG enhanced | |
| immunoturbidimetric | PEG enhanced | |
| immunoturbidimetric | ||
| Tracebility/Standardization | The value of Complement C4 has | |
| been assigned by using IFCC | ||
| preparate CRM 470 as a primary | ||
| reference. | IRMM reference Material | |
| CRM-470 from IFCC was | ||
| evaluated and found to recover | ||
| 103% of target concentration. | ||
| Sample Type | Human serum | Human serum |
| Reagent Stability | Reagents in unopened vials are | |
| stable at 2 ... 8 °C until the | ||
| expiration date printed on the | ||
| label. | Unopened reagents are stable | |
| until the expiration date printed | ||
| on the product label whwn | ||
| stored at 2°C - 8°C and | ||
| protected from light. | ||
| Expected Values | 10 - 40 mg/dl | 12 - 36 mg/dL |
| Instrument | T60i, T60i Kusti | ADVIA® 1650 Chemistry |
| system. | ||
| Measuring Range | 6* - 103* mg/dl | |
| (* The values are related to the | ||
| Complement C4 concentration of | ||
| the calibrator and are lot | ||
| dependent.). | From 0.36 mg/dL to the C3 | |
| concentration in the Liquid | ||
| Specific Protein Calibrator | ||
| Level 6 |
The following table compares the Complement C4 with the predicate device.
Table 2 Complement C4
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| Precision | Within run | Within run |
|---|---|---|
| Level 8 mg/dL | ||
| SD = 0.1 | ||
| CV(%) = 1.3 | Level 19.03 mg/dL | |
| SD = 0.21 | ||
| CV(%) = 1.1 | ||
| Level 8 mg/dL | ||
| SD = 0.1 | ||
| CV(%) = 1.5 | Level 35.51 mg/dL | |
| SD = 0.58 | ||
| CV(%) = 1.6 | ||
| Level 16 mg/dL | ||
| SD = 0.3 | ||
| CV(%) = 1.7 | Level 51.70 mg/dL | |
| SD = 1.50 | ||
| CV(%) = 2.9 | ||
| Level 46 mg/dL | ||
| SD = 1.0 | ||
| CV(%) = 2.2 | ||
| Level 78 mg/dL | ||
| SD = 0.8 | ||
| CV(%) = 1.0 | Total | |
| Level 19.03 mg/dL | ||
| SD = 0.76 | ||
| CV(%) = 4.0 | ||
| Level 88 mg/dL | ||
| SD = 0.7 | ||
| CV(%) = 0.8 | Level 35.51 mg/dL | |
| SD = 1.78 | ||
| CV(%) = 5.0 | ||
| Level 51.70 mg/dL | ||
| SD = 2.66 | ||
| CV(%) = 5.1 | ||
| Between run | ||
| Level 8 mg/dL | ||
| SD = 0.1 | ||
| CV(%) = 1.6 | ||
| Level 8 mg/dL | ||
| SD = 0.1 | ||
| CV(%) = 1.6 | ||
| Level 16 mg/dL | ||
| SD = 0.3 | ||
| CV(%) = 1.5 | ||
| Level 46 mg/dL | ||
| SD = 0.9 | ||
| CV(%) = 1.9 | ||
| Level 78 mg/dL | ||
| SD = 0.6 | ||
| CV(%) = 0.7 | ||
| Level 88 mg/dL | ||
| SD = 0.7 | ||
| CV(%) = 0.8 | ||
| Total | ||
| Level 8 mg/dL | ||
| SD = 0.2 | ||
| CV(%) = 2.8 | ||
| Level 8 mg/dL | ||
| SD = 0.2 | ||
| CV(%) = 2.7 | ||
| Level 16 mg/dL | ||
| SD = 0.6 | ||
| CV(%) = 3.5 | ||
| Level 46 mg/dL | ||
| SD = 2.0 |
. .
. . . . .
8
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| | CV(%) = 4.4
Level 78 mg/dL
SD = 1.4
CV(%) = 1.7
Level 88 mg/dL
SD = 1.5
CV(%) = 1.7 | |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Method Comparison | y = 0.99x – 0.18
R = 0.995
Range 3 to 88 mg/dl
N = 88 | Bayer RA Complement C4
reagent run on ADVIA 1650
Serum Y = 0.84x+2.33
r = 0.976
N = 50
Sample Range
10.1 – 59.1 mg/dL |
| Limitations | Lipemia:
No interference found up to 300
mg/dL (3 g/l) of Intralipid®.
Hemolysate:
No interference found up to 1000
mg/dL (10 g/l) of hemoglobin.
Bilirubin, conjugated:
No interference found up to 58
mg/dL (1000 µmol/l) of
conjugated bilirubin.
Bilirubin, unconjugated:
No interference found up to 58
mg/dL (1000 µmol/l) of
unconjugated bilirubin. | The following interferences
were tested up to the indicated
levels and found not to interfere:
Bilirubin (conjugated)
≤18.75 mg/dL
Bilirubin (unconjugated)
≤18.75 mg/dL
Hemoglobin
≤750 mg/dL
Triglyceride (concentrate)
≤1000 mg/dL |
:
:
Ratastic 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
a was "neimo om
:
9
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 9 2007
Thermo Electron Oy c/o Päivi Sormunen Vice President of QRC Ratastie2 P.O. Box 100 FIN-01621 Vantaa Finland
Re: K063150
Trade/Device Name: Complement C3, Complement C4, Specical Calibrator, Specitrol Control, Specitrol High Control Regulation Number: 21 CFR 866.5240 Regulation Name: Complement components immunological test system Regulatory Class: Class II Product Code: CZW, DBI, JIX, JJY Dated: November 7, 2006 Received: February 7, 2007
Dear Päivi 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 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); good manufacturing practice requirements as set
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forth in the quality systems (OS) regulation (21 CFR Part 820). 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) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Robert A. Becker, Jr.
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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SpeciCal
Beerial r of in vitro diagnosure ace on a cation of specific proteins in serum and plasma by immunoturbidimetry and for antigen excess detection using methods defined by Thermo Electron Oy
SpeciTrol
Specialized assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy
Specitrol High
For in vitro diagnostic use on T60 analyzer. Specitrol High is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy
Page 2 of 2
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Indications for Use
510(k) Number (if known): K063150
Device Names:
Complement C3 Specical calibrator Specitrol control Specitrol High control
Indications for Use:
Complement C3 is intended for quantitative in-vitro diagnostic determination of the complement C3 concentration in human serum using T60 Clinical Chemistry Analyzers. C3 measurement may aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
SpeciCal
For in vitro diagnostic use on T60 analyzer. SpeciCal protein calibrator is used as a stock calibrator for both quantification of specific proteins in serum and plasma by immunoturbidimetry and for antigen excess detection using methods defined by Thermo Electron Oy
SpeciTrol
For in vitro diagnostic use on T60 analyzer. SpeciTrol is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy
Specitrol High
For in vitro diagnostic use on T60 analyzer. Specitrol High is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy
Prescription Use X Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Maria M Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
510(k) K063150
22
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Indications for Use
510(k) Number (if known): K063150
Device Names:
Complement C4 Specical calibrator Specitrol control Specitrol High control
Indications for Use:
Complement C4 is intended for quantitative in-vitro diagnostic determination of the complement C4 concentration in human serum using T60 Clinical Chemistry Analyzers. C4 measurement may aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
SpeciCal
For in vitro diagnostic use on T60 analyzer. SpeciCal protein calibrator is used as a stock calibrator for both quantification of specific proteins in serum and plasma by immunoturbidimetry and for antigen excess detection using methods defined by Thermo Electron Oy
SpeciTrol
For in vitro diagnostic use on T60 analyzer. SpeciTrol is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy
Specitrol High
For in vitro diagnostic use on T60 analyzer. Specitrol High is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Maria M. Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
510(k) K063150
22