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. C3 and C4 measurements may aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Device Description

Not Found

AI/ML Overview

The provided document describes the Thermo Electron Oy Complement C3 and C4 diagnostic test systems, along with associated calibrators (SpeciCal) and controls (SpeciTrol and SpeciTrol High). These devices are intended for the quantitative determination of complement C3 and C4 concentrations in human serum on the T60 analyzer to aid in the diagnosis of immunologic disorders.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance characteristics for both Complement C3 and Complement C4, comparing the new device (Thermo Electron Oy's T60 analyzer) with predicate devices (Bayer Clinical Method for ADVIA 1650). The acceptance criteria are implied by the reported performance, which demonstrates comparable results to the legally marketed predicate devices.

Complement C3 Acceptance Criteria and Performance

Attribute	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (New Device)
Intended Use	Quantitative determination of complement C3 concentration in human serum on an ADVIA® Chemistry System, aiding in diagnosis of inherited/acquired deficiencies, inflammatory, and necrotic disorders.	Quantitative determination of complement C3 concentration in human serum on the T60 analyzer, aiding in diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. (Similar to predicate)
Assay Protocol	PEG enhanced immunoturbidimetric	PEG enhanced immunoturbidimetric (Same as predicate)
Traceability/ Standardization	IRMM reference Material CRM 470 from IFCC evaluated and found to recover 97% of target concentration.	Value of Complement C3 assigned using IFCC preparate CRM 470 as a primary reference. (Comparable to predicate)
Sample Type	Human serum	Human serum (Same as predicate)
Reagent Storage	Unopened reagents stable until expiration date at 2°C - 8°C, protected from light.	Reagents in unopened vials stable at 2...8 °C until expiration date. (Similar to predicate)
Measuring Range	0.46 mg/dL to the C3 concentration in the Liquid Specific Protein Calibrator Level 6.	28* – 513 mg/d* (*The values are related to the Complement C3 concentration of the calibrator and are lot dependent.) (Range covers/exceeds predicate)
Precision (Within run - CV%)	Level 64.02 mg/dL: 1.2% Level 124.13 mg/dL: 2.1% Level 182.35 mg/dL: 2.1%	Level 33 mg/dL: 1.4% Level 42 mg/dL: 1.3% Level 89 mg/dL: 0.8% Level 216 mg/dL: 0.9% Level 406 mg/dL: 0.8% Level 441 mg/dL: 0.5% (Comparable or better than predicate)
Precision (Total - CV%)	Level 64.02 mg/dL: 6.5% Level 124.13 mg/dL: 7.0% Level 182.35 mg/dL: 6.7%	Level 33 mg/dL: 3.7% Level 42 mg/dL: 3.0% Level 89 mg/dL: 2.3% Level 216 mg/dL: 2.4% Level 406 mg/dL: 1.8% Level 441 mg/dL: 2.0% (Significantly better than predicate)
Method Comparison	y = 1.06x - 6.47, r = 0.952 (for n=40 samples in range 44.6 - 250.6 mg/dL between Bayer RA Complement C3 reagent on ADVIA 1650 and predicate)	y = 0.98x + 4.99, R = 0.989 (for n=102 samples in range 28 to 299 mg/dL) (Slope closer to 1, higher R-value, broader range of samples compared to predicate's comparison method)
Limitations (Interference)	Bilirubin (conjugated) ≤ 25 mg/dL Bilirubin (unconjugated) ≤ 18.75 mg/dL Hemoglobin ≤ 1000 mg/dL Triglyceride (concentrate) ≤ 1000 mg/dL (No interference found up to these levels)	Lipemia: No interference up to 500 mg/dL (5 g/l) of Intralipid. Hemolysate: No interference up to 1000 mg/dl (10 g/l) of hemoglobin. Bilirubin, conjugated: No interference up to 58 mg/dL (1000 µmol/l). Bilirubin, unconjugated: No interference up to 58 mg/dl (1000 µmol/l). (Comparable or better than predicate in tested levels)

Complement C4 Acceptance Criteria and Performance

Attribute	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (New Device)
Intended Use	Quantitative determination of complement C4 concentration in human serum on an ADVIA® Chemistry System, aiding in diagnosis of inherited/acquired deficiencies, inflammatory, and necrotic disorders.	Quantitative determination of complement C4 concentration in human serum on the T60 analyzer, aiding in diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. (Similar to predicate)
Assay Protocol	PEG enhanced immunoturbidimetric	PEG enhanced immunoturbidimetric (Same as predicate)
Traceability/ Standardization	IRMM reference Material CRM-470 from IFCC evaluated and found to recover 103% of target concentration.	Value of Complement C4 assigned using IFCC preparate CRM 470 as a primary reference. (Comparable to predicate)
Sample Type	Human serum	Human serum (Same as predicate)
Reagent Stability	Unopened reagents stable until expiration date at 2°C - 8°C, protected from light.	Reagents in unopened vials stable at 2 ... 8 °C until expiration date. (Similar to predicate)
Measuring Range	From 0.36 mg/dL to the C3 concentration in the Liquid Specific Protein Calibrator Level 6.	6* - 103* mg/dl (*The values are related to the Complement C4 concentration of the calibrator and are lot dependent.) (Range covers/exceeds predicate)
Precision (Within run - CV%)	Level 19.03 mg/dL: 1.1% Level 35.51 mg/dL: 1.6% Level 51.70 mg/dL: 2.9%	Level 8 mg/dL: 1.3% & 1.5% Level 16 mg/dL: 1.7% Level 46 mg/dL: 2.2% Level 78 mg/dL: 1.0% Level 88 mg/dL: 0.8% (Comparable or better than predicate)
Precision (Total - CV%)	Level 19.03 mg/dL: 4.0% Level 35.51 mg/dL: 5.0% Level 51.70 mg/dL: 5.1%	Level 8 mg/dL: 2.8% & 2.7% Level 16 mg/dL: 3.5% Level 46 mg/dL: 4.4% Level 78 mg/dL: 1.7% Level 88 mg/dL: 1.7% (Better than predicate)
Method Comparison	y = 0.84x + 2.33, r = 0.976 (for n=50 samples in range 10.1 – 59.1 mg/dL between Bayer RA Complement C4 reagent on ADVIA 1650 and predicate)	y = 0.99x – 0.18, R = 0.995 (for n=88 samples in range 3 to 88 mg/dl) (Slope closer to 1, higher R-value, broader range of samples compared to predicate's comparison method)
Limitations (Interference)	Bilirubin (conjugated) ≤18.75 mg/dL Bilirubin (unconjugated) ≤18.75 mg/dL Hemoglobin ≤750 mg/dL Triglyceride (concentrate) ≤1000 mg/dL (No interference found up to these levels)	Lipemia: No interference up to 300 mg/dL (3 g/l) of Intralipid®. Hemolysate: No interference up to 1000 mg/dL (10 g/l) of hemoglobin. Bilirubin, conjugated: No interference up to 58 mg/dL (1000 µmol/l). Bilirubin, unconjugated: No interference up to 58 mg/dL (1000 µmol/l). (Comparable or better than predicate in tested levels)

2. Sample Sizes Used for the Test Set and Data Provenance

Complement C3:
- Method Comparison (Linearity/Accuracy): N = 102 samples.
- Precision: Not explicitly stated, but data is typically derived from replicate measurements of control materials or patient samples over several days/runs. The listed levels cover various concentrations (e.g., 33, 42, 89, 216, 406, 441 mg/dL).
- Interference: Specific levels of interferents (Intralipid, hemoglobin, conjugated bilirubin, unconjugated bilirubin) were tested.
- Data Provenance: Not explicitly stated, but typically these types of studies for in vitro diagnostic devices are prospective and conducted in a controlled laboratory environment. The country of origin is not mentioned.
Complement C4:
- Method Comparison (Linearity/Accuracy): N = 88 samples.
- Precision: Not explicitly stated, but data is typically derived from replicate measurements of control materials or patient samples over several days/runs. The listed levels cover various concentrations (e.g., 8, 16, 46, 78, 88 mg/dL).
- Interference: Specific levels of interferents (Intralipid, hemoglobin, conjugated bilirubin, unconjugated bilirubin) were tested.
- Data Provenance: Not explicitly stated, but typically these types of studies for in vitro diagnostic devices are prospective and conducted in a controlled laboratory environment. The country of origin is not mentioned.

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 in vitro diagnostic (IVD) devices, "ground truth" for method comparison and precision studies is typically established by comparing the new device's results to a more established, often FDA-cleared or gold standard, method (the predicate device in this case, on a different analyzer) or to known concentrations in control materials. The predicate devices are already considered to have an established "ground truth" for their measurements.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective interpretation (e.g., radiological reads) is involved and discrepancies need to be resolved. For quantitative in vitro diagnostic assays, the comparison is made directly between numerical results from the new device and the predicate device or reference values, not through an adjudication process by experts.

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 information is not applicable. This document describes an in vitro diagnostic (IVD) device, specifically a quantitative assay for complement proteins. It is not an AI-assisted diagnostic imaging device or a system that involves human readers interpreting data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is an automated chemistry analyzer (T60 analyzer) that performs quantitative measurements. The "algorithm" in this context refers to the assay's chemical reactions and measurement principles. The performance data presented (precision, linearity, method comparison, interference) reflects the standalone performance of the T60 analyzer with the specified reagents. There isn't a separate "algorithm only" component distinct from the device's operational performance that would be reported independently outside of human intervention. It is inherently a standalone analytical system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For these in vitro diagnostic assays, the "ground truth" for evaluating the new device's performance is established through:

Comparison to a Predicate Device/Method: The primary method comparison studies use the Bayer Clinical Method for ADVIA 1650 Complement C3 and C4 as the reference. The assumption for substantial equivalence is that the predicate device's results are considered accurate and reliable.
Reference Materials: For traceability and standardization, the IFCC preparate CRM 470 is used as a primary reference. This is a certified reference material with assigned values, serving as a form of "ground truth" for calibration.
Known Concentrations: For precision and linearity studies, control materials or spiked samples with known or established concentrations are typically used.

8. The Sample Size for the Training Set

This information is not applicable/provided. The described device is a quantitative in vitro diagnostic assay, not a machine learning or AI-based system that typically uses a "training set" in the computational sense. The "development" of the assay involves optimizing reagents and protocols, and validating performance on a test set (as described above), but not a data-driven training process in the way AI models are trained.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no "training set" in the context of this IVD device.

Summary

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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

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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

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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 thequantitative determination of thecomplement C3 concentration inhuman serum on the T60analyzer.	This in vitro diagnostic assay isintended to measure theconcentration of complement C3in human serum on an ADVIA®Chemistry System.Measurement of ComplementC3 levels is important in thedetermination of inherited oracquired deficiencies as well asthe diagnosis of inflammatoryand necrotic disorders.
Indication for Use	The complement C3 andcomplement C4 are intended forquantative in-vitro diagnosticdetermination of the complementC3 and C4 concentration inhuman serum using T60 ClinicalChemistry Analyzers. C3 and C4measurements may aid in thediagnosis of immunologicdisorders, especially thoseassociated with deficiencies ofcomplement components.	See intended use.
Assay Protocol	PEG enhancedimmunoturbidimetric.	PEG enhancedimmunoturbidimetric.
Traceability/Standardization	The value of Complement C3 hasbeen assigned by using IFCCpreparate CRM 470 as a primaryreference.	IRMM reference Material CRM470 from IFCC was evaluatedand found to recover 97% oftarget concentration.
Sample Type	Human serum	Human serum.
Reagent Storage	Reagents in unopened vials arestable at 2...8 °C until theexpiration date printed on thelabel.	Unopened reagents are stableuntil the expiration date printedon the product label when storedat 2°C - 8°C and protected fromlight.

Table 1 Complement C3

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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 theComplement C3 concentration ofthe calibrator and are lotdependent.)	0.46 mg/dL to the C3concentration in the LiquidSpecific Protein CalibratorLevel 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 = 0.9CV(%) = 1.0
	Level 216 mg/dLSD = 1.2CV(%) = 0.6
	Level 406 mg/dLSD = 4.3CV% = 1.1
	Level 441 mg/dLSD = 5.2CV% = 1.2
	Total
	Level 33 mg/dLSD = 1.2CV% = 3.7
	Level 42 mg/dLSD = 1.3CV% = 3.0
	Level 89 mg/dLSD = 2.1CV(%) = 2.3
	Level 216 mg/dLSD = 5.3CV(%) = 2.4
	Level 406 mg/dLSD = 7.4CV% = 1.8
	Level 441 mg/dLSD = 9.0CV% = 2.0
Method Comparison	y = 0.98x + 4.99R = 0.989Range 28 to 299 mg/dLN = 102	Bayer RA Complement C3reagent run on ADVIA 1650Serum Y = 1.06x-6.47r = 0.952N = 40Sample Range44.6 - 250.6 mg/dL

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Thermo Electron Oy

Ratastic 2
P.O. Box 100
FIN-01621 Vantaa
Finland

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Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki

www.alicensure.org

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Limitations	Lipemia:	The following interferenceswere tested up to the indicatedlevels and found not to interfere.
	No interference found up to 500mg/dL (5 g/l) of Intralipid.	Bilirubin (conjugated) $\leq$ 25 mg/dL
	Hemolysate:No interference found up to 1000mg/dl (10 g/l) of hemoglobin.	Bilirubin (unconjugated) $\leq$ 18.75 mg/dL
	Bilirubin, conjugated:No interference found up to 58mg/dL (1000 µmol/l) ofconjugated bilirubin.	Hemoglobin $\leq$ 1000 mg/dL
	Bilirubin, unconjugated:No interference found up to 58mg/dl (1000 µmol/l) ofunconjugated bilirubin.	Triglyceride (concentrate) $\leq$ 1000 mg/dL

Thermo Electron Oy

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Table 2 Complement C4Attribute	New device #1	Predicate device #1
Intended Use	For in vitro diagnostic use in thequantitative determination of thecomplement C4 concentration inhuman serum on the T60analyzer.	This in vitro diagnostic assay isintended to measure theconcentration of complement C4in human serum on an ADVIA®Chemistry System.Measurement of ComplementC4 levels is important in thedetermination of inherited oracquired deficiencies as well asthe diagnosis of inflammatoryand necrotic disorders.
Indication for Use	The complement C3 andcomplement C4 are intended forquantative in-vitro diagnosticdetermination of the complementC3 and C4 concentration inhuman serum using T60 ClinicalChemistry Analyzers. C3 and C4measurements may aid in thediagnosis of immunologicdisorders, especially thoseassociated with deficiencies ofcomplement components.	See intended use
Assay Protocol	PEG enhancedimmunoturbidimetric	PEG enhancedimmunoturbidimetric
Tracebility/Standardization	The value of Complement C4 hasbeen assigned by using IFCCpreparate CRM 470 as a primaryreference.	IRMM reference MaterialCRM-470 from IFCC wasevaluated and found to recover103% of target concentration.
Sample Type	Human serum	Human serum
Reagent Stability	Reagents in unopened vials arestable at 2 ... 8 °C until theexpiration date printed on thelabel.	Unopened reagents are stableuntil the expiration date printedon the product label whwnstored at 2°C - 8°C andprotected from light.
Expected Values	10 - 40 mg/dl	12 - 36 mg/dL
Instrument	T60i, T60i Kusti	ADVIA® 1650 Chemistrysystem.
Measuring Range	6* - 103* mg/dl(* The values are related to theComplement C4 concentration ofthe calibrator and are lotdependent.).	From 0.36 mg/dL to the C3concentration in the LiquidSpecific Protein CalibratorLevel 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/dLSD = 0.1CV(%) = 1.3	Level 19.03 mg/dLSD = 0.21CV(%) = 1.1
	Level 8 mg/dLSD = 0.1CV(%) = 1.5	Level 35.51 mg/dLSD = 0.58CV(%) = 1.6
	Level 16 mg/dLSD = 0.3CV(%) = 1.7	Level 51.70 mg/dLSD = 1.50CV(%) = 2.9
	Level 46 mg/dLSD = 1.0CV(%) = 2.2
	Level 78 mg/dLSD = 0.8CV(%) = 1.0	TotalLevel 19.03 mg/dLSD = 0.76CV(%) = 4.0
	Level 88 mg/dLSD = 0.7CV(%) = 0.8	Level 35.51 mg/dLSD = 1.78CV(%) = 5.0
		Level 51.70 mg/dLSD = 2.66CV(%) = 5.1
	Between run
	Level 8 mg/dLSD = 0.1CV(%) = 1.6
	Level 8 mg/dLSD = 0.1CV(%) = 1.6
	Level 16 mg/dLSD = 0.3CV(%) = 1.5
	Level 46 mg/dLSD = 0.9CV(%) = 1.9
	Level 78 mg/dLSD = 0.6CV(%) = 0.7
	Level 88 mg/dLSD = 0.7CV(%) = 0.8
	Total
	Level 8 mg/dLSD = 0.2CV(%) = 2.8
	Level 8 mg/dLSD = 0.2CV(%) = 2.7
	Level 16 mg/dLSD = 0.6CV(%) = 3.5
	Level 46 mg/dLSD = 2.0

. .

. . . . .

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	CV(%) = 4.4Level 78 mg/dLSD = 1.4CV(%) = 1.7Level 88 mg/dLSD = 1.5CV(%) = 1.7
Method Comparison	y = 0.99x – 0.18R = 0.995Range 3 to 88 mg/dlN = 88	Bayer RA Complement C4reagent run on ADVIA 1650Serum Y = 0.84x+2.33r = 0.976N = 50Sample Range10.1 – 59.1 mg/dL
Limitations	Lipemia:No interference found up to 300mg/dL (3 g/l) of Intralipid®.Hemolysate:No interference found up to 1000mg/dL (10 g/l) of hemoglobin.Bilirubin, conjugated:No interference found up to 58mg/dL (1000 µmol/l) ofconjugated bilirubin.Bilirubin, unconjugated:No interference found up to 58mg/dL (1000 µmol/l) ofunconjugated bilirubin.	The following interferenceswere tested up to the indicatedlevels and found not to interfere:Bilirubin (conjugated)≤18.75 mg/dLBilirubin (unconjugated)≤18.75 mg/dLHemoglobin≤750 mg/dLTriglyceride (concentrate)≤1000 mg/dL

Ratastic 2
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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

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{12}------------------------------------------------

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

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

{13}------------------------------------------------

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

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

Regulation Number and Section

§ 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).