What is the regulatory pathway for COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL?

510(k) clearance (submission type: Traditional).

What are the predicate devices for COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL?

Bayer Clinical Method for ADVIA 1650 Complement C3 (C3); Bayer Clinical Method for ADVIA 1650 Complement C4 (C4); Liquid Specific Protein Calibrator, Bayer USA (k033791); Liquid Assayed Immunology Controls 1 and 3, Medical Analysis Systems USA (k960824).

Who can help prepare an FDA 510(k) submission like COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL

Q: Who is the manufacturer of COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL?

Thermo Electron OY filed the 510(k) submission for COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL (K063150).

Q: What is the FDA product code for COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL?

CZW. It is classified under 21 CFR 866.5240 as a Class 2 device in the Immunology panel.

K063150 · Thermo Electron OY · CZW · Mar 19, 2007 · Immunology

Device Facts

Record ID	K063150
Device Name	COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
Applicant	Thermo Electron OY
Product Code	CZW · Immunology
Decision Date	Mar 19, 2007
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.5240
Device Class	Class 2

Intended Use

The Complement C3 is for in vitro diagnostic use in the quantitative determination of the complement C3 concentration in human serum on the T60 analyzer. The Complement C4 is for in vitro diagnostic use in the quantitative determination of the complement C4 concentration in human serum on the T60 analyzer. SpeciCal protein calibrator is 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 excel detection using methods defined by Thermo Electron Oy. Specitrol is for in vitro diagnostic use on T60 analyzer. Specitrol is intended to be used as assayed control serum to monitor precision of specific protein tests on the T60 analyzer defined by Thermo Electron Oy. Specitrol High is 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 on the T60 analyzer defined by Thermo Electron Oy.

Device Story

System comprises Complement C3 and C4 reagents, SpeciCal calibrator, and SpeciTrol/Specitrol High controls for use on T60 Clinical Chemistry Analyzers. Input: human serum samples. Principle: PEG-enhanced immunoturbidimetry. Output: quantitative concentration values for C3 and C4. Used in clinical laboratory settings by trained personnel. Healthcare providers use results to aid in diagnosing immunologic disorders and complement deficiencies. Benefits include standardized, precise measurement of complement proteins to support clinical decision-making.

Clinical Evidence

Bench testing only. Precision studies (CLSI EP5-A2) conducted over 21 days showed total CVs ranging from 1.8% to 3.7% for C3 and 1.7% to 4.4% for C4. Linearity (CLSI EP6-A) confirmed measuring ranges of 28-513 mg/dL (C3) and 6-103 mg/dL (C4). Method comparison (CLSI EP9-A2) against predicate yielded Deming regression slopes of 0.980 (C3, R=0.989) and 0.989 (C4, R=0.995). Interference testing (CLSI EP7-A2) evaluated hemoglobin, bilirubin, and lipemia (Intralipid). No clinical sensitivity/specificity data provided.

Technological Characteristics

PEG-enhanced immunoturbidimetric assay. Reagents: rabbit antiserum, Tris/PEG buffer, PBS diluent. Energy source: optical (absorbance at 340 nm). Connectivity: DPC T60 analyzer integration. Calibration: CRM 470 traceable. Measuring range: C3 (28-513 mg/dL), C4 (6-103 mg/dL).

Indications for Use

Indicated for use in adults to aid in the diagnosis of immunologic disorders, particularly those associated with deficiencies of complement components C3 and C4. Performance not established in pediatric populations.

Regulatory Classification

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.

Predicate Devices

Bayer Clinical Method for ADVIA 1650 Complement C3 (C3)
Bayer Clinical Method for ADVIA 1650 Complement C4 (C4)
Liquid Specific Protein Calibrator, Bayer USA (k033791)
Liquid Assayed Immunology Controls 1 and 3, Medical Analysis Systems USA (k960824)

Related Devices

K032035 — SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI · Beckman Coulter, Inc. · Aug 7, 2003
K042494 — VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III · Ortho-Clinical Diagnostics · Oct 19, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "Thermo" in large, bold, black letters. Below the word "Thermo" is the phrase "ELECTRON CORPORATION" in smaller, lighter letters. The text appears to be a logo or brand name. # 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}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Thermo Electron Corporation. The word "Thermo" is in large, bold, black letters. Below it, in smaller, lighter letters, is the phrase "ELECTRON CORPORATION." # 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}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Thermo Electron Corporation. The word "Thermo" is in large, bold, black letters. Below it, in smaller letters, is the text "ELECTRON CORPORATION". 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 +358 (9) 3291 0500 fax Y-tunnus 0921547-0 VAT No FI09215470 Domicile Holsinki a sex the new call {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Thermo Electron Corporation. The word "Thermo" is in large, bold, black letters. Below it, in smaller letters, is the phrase "ELECTRON CORPORAL ON." | 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}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "Thermo" in large, bold, black letters. Below the word "Thermo" is the phrase "ELECTRON CORPORATION" in smaller, gray letters. The text appears to be a logo or brand name. . 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 www.alicensure.org {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "Thermo" in large, bold letters. Below the word "Thermo" is the phrase "ELECTRON CORPORATION" in smaller letters. The text is black and the background is white. | 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 o www.ibcom.cn.un {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 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "Thermo" in large, bold, black letters. Below the word "Thermo" is the phrase "ELECTION CORPORAL" in smaller, lighter letters. The text appears to be a logo or brand name. | 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}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "Thermo" in a bold, sans-serif font. Below the word "Thermo" is the phrase "ELECTRON CORPORATION" in a smaller, less bold font. The text is black against a white background. | | 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}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized graphic of an abstract human figure with three flowing lines emanating from it, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle. 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 {10}------------------------------------------------ Page 2 - 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 {11}------------------------------------------------ # 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 {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 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 {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 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

COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL

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COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL

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