Who is the manufacturer of HIGH METABOLITE QUALICHECK?

Radiometer Medical Aps filed the 510(k) submission for HIGH METABOLITE QUALICHECK (K130415).

What is the FDA product code for HIGH METABOLITE QUALICHECK?

JJS. It is classified under 21 CFR 862.1660 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for HIGH METABOLITE QUALICHECK?

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

Who can help prepare an FDA 510(k) submission like HIGH METABOLITE QUALICHECK?

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.

HIGH METABOLITE QUALICHECK

K130415 · Radiometer Medical Aps · JJS · Mar 26, 2013 · Clinical Chemistry

Device Facts

Record ID	K130415
Device Name	HIGH METABOLITE QUALICHECK
Applicant	Radiometer Medical Aps
Product Code	JJS · Clinical Chemistry
Decision Date	Mar 26, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1660
Device Class	Class 1

Intended Use

This High Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. Analytes are: pO2, ctHb, cGlucose, cLactate

Device Story

High Metabolite QUALICHECK is an aqueous quality control solution containing biological buffer, salts, metabolites, and preservatives. It is used by laboratory professionals to verify the accuracy and precision of blood gas and metabolite analyzers (e.g., ABL800, ABL77 series). The device is supplied in single-use ampoules. Users measure the control solution on the analyzer; the resulting values are compared against target ranges provided in the product insert to ensure the analyzer is performing within specifications. This process helps maintain the reliability of clinical diagnostic results for patients.

Clinical Evidence

Bench testing only. Value assignment was performed by sampling 72 ampoules from a reference batch and 72 ampoules from the subject batch. Measurements were conducted on three validated ABL7xx series analyzers, with 144 total measurements per parameter. Target ranges were calculated based on the mean ± 2SD.

Technological Characteristics

Aqueous solution containing biological buffer, salts, metabolites, and preservatives (Germall II, Kathon). Single-level control. Supplied in 2 mL ampoules. Compatible with ABL800 and ABL77 series analyzers. Storage at 2 °C to 8 °C.

Indications for Use

Indicated for use as an assayed quality control system to evaluate the accuracy and precision of pO2, ctHb, cGlucose, and cLactate measurements on compatible clinical analyzers.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

QUALICHECK5+ (K980135)

Related Devices

K150226 — Hematocrit and Metabolite QUALICHECK · Radiometer Medical Aps · May 13, 2015
K130236 — RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 · Radiometer Medical Aps · Mar 15, 2013
K961354 — QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) · Radiometer America, Inc. · Jun 14, 1996
K961355 — MULTICHECK · Radiometer America, Inc. · Jun 14, 1996
K980135 — QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 · Radiometer America, Inc. · Jan 28, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ Traditional 510(k): High Metabolite OUALICHECK # RADIOMETER K130415 ## Section 5. 510(k) Summary ## 1 Administrative Device Information High Metabolite QUALICHECK Device Name: Common Name: Quality Control Product Code: ાદ Registration Number: 21 CFR 862.1660 Classification: Class I Classification Panel: Clinical Chemistry | Submitter | | |---------------|---------------------------------------------| | Company Name: | Radiometer Medical ApS | | ER Number: | 3002807968 | | Address: | Aakandevej 21 2700 Broenshoej Denmark | | Phone: | +45 3827 3827 | | Fax: | +45 3827 2727 | ## 2 Description of Device High Metabolite QUALICHECK is a single level quality control system consisting of: - High Metabolite QUALICHECK (S7570) . The system consists of 30 ampoules per box. One ampoule contains 2 mL of solution. The quality control solution is an aqueous solution containing a biological buffer, salts, metabolites, and a preservative. #### 3 Intended Use This High Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. Analytes are: pO2, ctHb, cGlucose, cLactate ## 4 Substantial Equivalence The High Metabolite QUALICHECK is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate: 510(k) Number/Device Manufacturer: K980135 QUALICHECK5+, Radiometer Medical ApS **MAR 26 2013** {1}------------------------------------------------ : · | Similarities | | | | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | Issue | SE Device | Predicate: QUALICHECK5+ (K980135) | | | Form | Same | Liquid | | | Base matrix | Same | Aqueous solution | | | Blood Gas Measurement | Same | $pO_2$ | | | Oximetry Measurement | Same | ctHb | | | Metabolite Measurement | Same | cGlucose, cLactate | | | Compatible analyzers | Same | ABL520 ABL555 ABL600/605/610/615/620/625 ABL700/705/710/715/720/725/730/735 ABL805/810/815/820/825/830/835/ BASIC EML 105 | | | Differences | | | | | Issue | SE Device | Predicate: QUALICHECK5+ (K980135) | | | Intended Use | This High Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. Analytes are: pO2, ctHb, cGlucose, cLactate | For In Vitro Diagnostic Use. This QUALICHECK5+ solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. For professional use. | | | Storage | 2 °C to 8 °C until expiration date. | 2 °C to 25 °C until expiration date, including up to a total of 15 days at up to 32 °C | | | Open Vial Claim | High Metabolite QUALICHECK solutions are light and heat sensitive. Avoid storage in direct sunlight. Use immediately after opening the ampoule | Ampoules should be conditioned for at least five hours at a constant temperature between 18 °C and 32 °C before use. To maintain the reliability of the blood gas parameters, you must use the contents of the ampoule immediately after opening and according to the instructions in the operator's manual for the relevant analyzer. | | | Preservatives | Germall II, Kathon | ProClin 950 | | | Blood Gas Measurement | pH, pCO2 not included | pH, pO2, pCO2 in all four levels | | | Oximetry Measurement | sO2 FO2Hb, FCOHb, FMetHb, FHbf not included | sO2 FO2Hb, FCOHb, FMetHb, FHbf in all four levels | | | Electrolyte Measurement | Electrolyte Measurement not included | cK+, cNa+, cCa2+, cCl | | | Hemoglobin Measurement | Hemoglobin Measurement not included | ctBil | | | Levels | One level | Four levels | | | Target ranges | Target ranges, see Section 12.02 Target values | Target ranges, see Section 12.02 Target values | | | Compatible analyzers | ABL800 ABL817/827/837 ABL77 | ABL5 ABL500/510 ABL505 ABL80 - CO-OX SW ABL80 - OSM SW | | | | 4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | Differences | | | Ssue | | SE Device | Predicate: QUALICHECK5+ (K980135) | | | | | ABL90 Flex | 11 - 11 - 11 - and the comments of the comments of the comments of and the comments of the comments of the comments of the comments of ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {2}------------------------------------------------ . . 。 . . ・ ______________________________________________________________________________________________________________________________________________________________________________ .. {3}------------------------------------------------ #### 5. Stability Stability studies and claims are based on real time stability study. Control solutions are stable for 2 years at 2-8 degrees C. In-use Stability: The contents should be used immediately after opening. #### 6. Value Assignment To determine the assigned values and control ranges for the High Metabolite QUALICHECK, six (6) trays of 1000 ampoules are sampled randomly from the Range+ QUALICHECK batch. Twelve ampoules are sampled from each of the trays and 72 ampoules are sampled from the reference batch. The samples are conditioned and shaken at 25°C in a water bath for 6 hours. Measurements are performed on a minimum of 3 validated ABL7xx series with data collection. Measurement of each parameter is performed alternately on the reference ampoule and the sample and repeated 12 times on each ABL7xx for a total of 144 measurements. Target ranges are calculated based on the mean ±2SD. #### 7. Conclusion The High Metabolite QUALICHECK is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate device: QUALICHECK5+ (K980135). {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The symbol is black, and the text is also black. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 26, 2013 Radiometer Medical Aps c/o Martin Gabler Aakandevej 21, Broenshoej DENMARK DK-2700 Re: k130415 Trade/Device Name: High Metabolite QUALICHECK Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: I, reserved Product Code: JJS Dated: February 06, 2013 Received: February 19, 2013 Dear Mr. Gabler: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for {5}------------------------------------------------ Page 2-Mr. Gabler the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Carol C. Benson -S for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): k130415 Device Name: High Metabolite QUALICHECK Indications for Use: This High Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. Analytes are: pO2, ctHb, cGlucose, cLactate Prescription Use X (21 CFR Part 801 Subpart D) And/Or Over the Counter Use _ (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) YungW.D.Chan-S Division Sign-Off Office of In Vitro Diagnostics and Radiological Health 510(k)