(26 days)
Not Found
No
The summary describes a standard blood gas analyzer with no mention of AI/ML features or related performance metrics.
No
The device is a blood gas analyzer, which is a diagnostic tool that measures various parameters in blood. It does not treat or alleviate a disease or condition.
Yes
The device measures various parameters in human blood (e.g., pH, pCO2, pO2, glucose, lactate) which are used by healthcare professionals to diagnose and monitor medical conditions.
No
The device description clearly states it is a physical analyzer with dimensions and weight, indicating it is a hardware device.
Yes, based on the provided information, the ABL700 Series device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it "measures pH, pCO2, pO2 cNat, cK+, cCa+, cCL;, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood, and pO2 and pCO2 on expired air." This involves testing biological samples (blood and expired air) outside of the body to provide information about a person's health status.
- Device Description: It's described as an "automated blood gas, co-oximetry electrolyte and metabolite analyzer." These types of analyzers are standard IVD devices used in clinical settings for diagnostic purposes.
The core function of analyzing biological samples to provide diagnostic information aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ABL700 Series is a stand-alone blood gas analyzer that measures pH, pCO2, pO2 cNat, cK+, cCa+, cCL;, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood, and pO2 and pCO2 on expired air.
Product codes
CHL, JFP, CGZ, CGA, KHP, CEM, JGS
Device Description
ABL700 Series, is an automated blood gas, co-oximetry electrolyte and metabolite analyzer that is 44 cm x 70 cm x 50 cm (HWD) and weighs 30 kg. It measures on whole blood in approximately 60 seconds.
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
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Key Metrics
Not Found
Predicate Device(s)
ABL625 (K962334), ABL555 (K973367)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.
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HSC130
16
RADIOMETER AMERICA INC.
MEDICAL DIVISION
- 1998
EXHIBIT VI
811 SHARON DRIVE, WESTLAKE, OHIO 44145-1688 800-736-0600, 218-871-8
510(k) SUMMARY SUBJECT:
- FROM: Donald L. Baker Director of Marketing and Regulatory Affairs Radiometer America Inc. 810 Sharon Drive Westlake, Ohio 44145 (440)871-8900, Ext. 287 or 1-800-736-0600 Fax (440)871-2633
- January 5, 1998 DATE:
- Trade Name: ABL700 Series PRODUCT: Common Name: Blood Gas, Co-oximetry, Electrolyte and Metabolite Measuring System Classification Name: Blood Gas
PREDICATE
ABL625 and ABL555 DEVICE:
PRODUCT
- DESCRIPTION: ABL700 Series, is an automated blood gas, co-oximetry electrolyte and metabolite analyzer that is 44 cm x 70 cm x 50 cm (HWD) and weighs 30 kg. It measures on whole blood in approximately 60 seconds.
INTENDED
- ABL700 Series is a stand-alone blood gas analyzer that measures pH, pCO2, USE: pO2 cNat, cK+, cCa+, cCL;, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood, and pO2 and pCO2 on expired air.
TECHNOLOGICAL CHARACTERISTICS
VERSUS PREDICATE
ABL700 Series is technologically similar to the ABL625 and ABL555. DEVICE:
SUBSTANTIAL EQUIVALENCE:
ABL700 Series is substantially equivalent in features and characteristics to the current ABL625 (K962334) and ABL555 (K973367) marketed by Radiometer America Inc.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, 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
FEB - 9 1008
Donald L. Baker · Director of Marketing and Regulatory Affairs Radiometer America, Inc. 811 Sharon Drive Westlake, Ohio 44145-1598
Re : K980130 ABL700 Series Analyzer Regulatory Class: I & II Product Code: CHL, JFP, CGZ, CGA, KHP, CEM, JGS January 5, 1997 Dated: January 14, 1997 Received:
Dear Mr. Baker:
regulations.
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈਂ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set -forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic
Product Radiation Control provisions, or other Federal laws or
2
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (Size Co), Child Concernine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acious in your may 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
EXHIBIT V
510(k) NUMBER (IF KNOWN): ____________________________________________________________________________________________________________________________________________________
DEVICE NAME: _________________________________________________________________________________________________________________________________________________________________
INDICATIONS FOR USE:
ABL700 Series is a stand-alone blood gas analyzer that measures pH, pCO2, p02 , cNat, cK+, cCa+, cCL, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood, and pO2 and pCO2 on expired air.
P. Bierhaus (Lois A. Montgomery)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K980130
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
(Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801-109)
Over-The-Counter-Use (Optional Format 1-2-96)