ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)

K110394 · Vital Diagnostics (Manufacturing) Ptyltd · JIX · Jun 9, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110394
• Device Name: ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
• Applicant: Vital Diagnostics (Manufacturing) Ptyltd
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jun 9, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The ATAC Serum Calibrator is intended for use with the ATAC Clinical Systems to establish points of reference that are used in the determination of albumin, calcium, cholesterol, creatinine, direct bilirubin, glucose, iron, magnesium, phosphorus, total bilirubin, total protein, triglycerides, urea and uric acid in human specimens..

Device Story

ATAC Serum Calibrator is a lyophilized human serum-based product containing multiple analytes (albumin, calcium, cholesterol, creatinine, direct bilirubin, glucose, iron, magnesium, phosphorus, total bilirubin, total protein, triglycerides, urea, uric acid). Used with ATAC 8000 Random Access Chemistry Analyzer to establish reference points for clinical chemistry assays. Kit includes 4 vials of calibrator and 4 vials of diluent. Source material tested non-reactive for HIV1/2, HBsAg, and HCV. Healthcare providers use the system to calibrate assays for patient specimen analysis, ensuring accurate quantitative measurement of clinical chemistry markers.

Clinical Evidence

No clinical data. Bench testing only. Stability claims supported by real-time and accelerated stability protocols. Traceability established via NIST SRM reference materials (e.g., SRM 927, 915b, 914, 917b, 937, 929, 916a, 1951b, 912a, 913a).

Technological Characteristics

Serum-based calibrator; liquid or lyophilized form (implied by product type); intended for use with ATAC Clinical Systems; Class II device (21 CFR 862.1150).

Indications for Use

Indicated for use with ATAC Clinical Systems to calibrate assays for albumin, calcium, cholesterol, creatinine, direct bilirubin, glucose, iron, magnesium, phosphorus, total bilirubin, total protein, triglycerides, urea, and uric acid in human specimens.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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Public Health Service

Vital Diagnostics c/o Ms. Melita Lambiris Technical and Regulatory Affairs Manager 189-199 Browns Road, Noble Park Victoria. 3174, Australia

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

k110394 Re:

K110594
Trade Name: ATAC serum calibrator (direct bilirubin and iron) Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: May 17, 2011 JUN - 9 2011 Received: May 19, 2011

Dear Ms. Melita Lambiris:

We have reviewed your Section 510(k) premarket notification of intent to market the We have reviewed your Sector 910(t) promation is substantially equivalent (for device felefenced above and nare decembere) to legally marketed predicate devices
the indications for use stated in the enclosure) to legally marketed predicate of the marketed in interstate commerce prior to May 28, 1976, the enactment date of the marketed in mersiale commerce prior to they = that have been reclassified in accordance Medical Device Antendinents, of to devices and Cosmetic Act (Act) that do not require
with the provisions of the Federal Food, Drug, and Cosmetic Act (act the with the provisions of the Federal Pood, Drag, MA). You may, therefore, market the approval of a premarker approval upproval upprovisions of the Act. The general controls device, subject to the general controls pro the mnual registration, listing of devices,
provisions of the Act include requirements for annual registration and provisions of the Act merade requiring and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III
n and the manages that the cases of the cases of the Fricting major regulations If your device is classified (see above) into controls. Existing major regulations (CF (PMA), if may be subject to such adontonal of the 21, Code of Federal Regulations (CFR), Parts
affecting your device can be found in Title 21, Code of Federal Regulations vou arrecting your device can be round in Tiss Luther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does Please be advised that FDA s issuance of the month is and device complies with other not mean that FDA has made a determination and regulations administered by other requirements of the Act of ally I colul statution and signerements, including, but not
Federal agencies. You must comply with all the Act 's requirements, including (21 CER Federal agencies. Fourmust compry with and 07); labeling (21 CFR Parts 801 and limited to: registration and listing (2) CFR Parcoon) lastics arents) (21)
809); medical device reporting (reporting of medical devices events) (21 809); medical device reporting (riporting of measurements as set forth in the quality
CFR 803); and good manufacturing practice requirements as set forth in the quality
contr systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Signature

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): k110394

Device Name: ATAC Serum Calibrator

Indications for Use:

. "

The ATAC Serum Calibrator is intended for use with the ATAC Clinical Systems to establish points of reference that are used in the determination of albumin, calcium, cholesterol, creatinine, direct bilirubin, glucose, iron, magnesium, phosphorus, total bilirubin, total protein, triglycerides, urea and uric acid in human specimens.

x Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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)

Division Officer

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110394

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