(138 days)
No
The description focuses on automated mechanical and software control of quality control procedures, with no mention of AI or ML algorithms for data analysis, interpretation, or decision-making beyond standard automated processes.
No
The device is a blood gas analyzer that measures various parameters in blood and includes an auto-check module for performing automated analysis of quality control fluids. It is designed for diagnostic and quality control purposes, not for treating or preventing disease.
Yes
The device measures pH, pCO2, pO2, cNa+, cK+, cCa2+, cCL-, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood, which are diagnostic measurements.
No
The device description clearly states that the AutoCheck module is a physical component that is physically installed into the ABL700 Series Analyzer and includes hardware such as an ampoule carrousel and a bar code reader. While it includes upgraded software, it is not solely software.
Based on the provided information, the ABL700 Series Analyzer with the AutoCheck module is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device "measures pH, pCO2, pO2, cNa+, cK+, cCa2+, cCL-, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood." This is a classic description of an in vitro diagnostic test performed on a human specimen (blood) to provide information about a person's health.
- Device Description: The description details a device that analyzes blood samples. While the AutoCheck module focuses on quality control, the core function of the ABL700 Series Analyzer is to perform diagnostic measurements on blood.
- Predicate Devices: The predicate devices listed, such as the RADIOMETER ABL700 Series and AVL9181 Electrolyte Analyzer, are also IVD devices. This further supports the classification of the described device as an IVD.
The AutoCheck module itself, while focused on quality control, is an accessory or component that enhances the functionality of the core IVD device (the ABL700 Series Analyzer). The combined system is still considered an IVD because its primary purpose is to perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ABL700 Series Analyzer with the AutoCheck module is a stand-alone blood gas analyzer that measures pH, pCO2, pO2, cNa+, cK+, cCa2+, cCL-, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood. The AutoCheck Module is an added functionality to perform automated analysis of quality control fluids.
Product codes (comma separated list FDA assigned to the subject device)
CHL, JFP, CGZ, CGA, KHP, CEM, JGS, GKF, JJS, KHP
Device Description
The ABL700 Series Analyzer with the AutoCheck module is an ABL700 Analyzer with the added capability of performing automated analysis of quality control fluids. The AutoCheck module is designed to work with a quality control fluid system named AutoCheck 5+. The AutoCheck 5+ is an ampouled four level quality control fluid system. The composition of the various levels of Quality control fluids in AutoCheck 5+ correspond to the composition of the corresponding levels of Qualicheck 5+ system (K980135).
The AutoCheck 5+ ampoules comprise a cap on the top of the ampoules designed to break the top of an ampoule when it is to be used. Furthermore, each ampoule has a bar code containing information on the specific level and lot of the quality control fluid.
Installing an AutoCheck module into an existing ABL700 Series Analyzer includes physically installing the module and loading upgraded software which controls the function of the AutoCheck module. The AutoCheck module comprises an ampoule carrousel carrying 20 ampoules of quality control fluid and further comprises a bar code reader for reading the bar code located on each ampoule. When installed into the ABL700 Series Analyzer, the AutoCheck module automatically performs the quality control of the analyzer. Thus, when a quality control is due, the analyzer warns the user and if the user accepts, the quality control is performed. The software selects the appropriate ampoule, the AutoCheck module opens the ampoule by pressing the cap through the top of the ampoule, the quality control fluid is automatically introduced into the analyzer inlet and the measurements are performed. The upgraded software controls all steps. If required, a manual quality control may be performed as well.
The automatic inlet of sample loaded into a carrousel is a principle, which is well known from various types of analyzers. Thus, it is well known in coagulation and/or urine analyzers that the samples to be measured are loaded with a sample carrousel. Also, the AVL9181 Electrolyte Analyzer (K972673) for measuring electrolytes in i. a. whole blood, serum, or plasma comprises a built-in autosampler. For further details of performing the automatic quality control in the ABL700 Series Analyzer with the AutoCheck module I refer to the enclosed sections of the Operator's Manual.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
RADIOMETER AMERICA INC.
MEDICAL DIVISION
810 SHARON DRIVE, WESTLAKE, OHIO 44145
810 SHARON DRIVE, 800-736-0600, 440-871-8900
JAN 1 0 2000
| SUBJECT: | 510(K) SUMMARY NUMBER: K992859 |
|---|---|
| FROM: | Vince Sigmund |
| Manager of Customer Relations & Technical Support | |
| Radiometer America Inc. | |
| 810 Sharon Drive | |
| Westlake, Ohio 44145 | |
| (440)871-8900, Ext. 209 or 1-800-736-0600 | |
| Fax (440)871-2633 871- 2510 | |
| DATE: | November 22, 1999 |
| PRODUCT: | Trade Name: ABL700 with AutoCheck Module |
| Common Name: pH/Blood Gas/Co-oximetry/Electrolyte/Metabolyte | |
| Analyzer | |
| Classification Name: Blood Gas and Blood pH Test System | |
| PREDICATE DEVICE: | RADIOMETER ABL700 Series (K980130, RADIOMETER Qualicheck 5+ |
| (K980135) and AVL9181 Electrolyte Analyzer (K972673). | |
| PRODUCT DESCRIPTION: | The ABL700 Series Analyzer with the AutoCheck module is an ABL700 |
| Analyzer with the added capability of performing automated analysis of | |
| quality control fluids. The AutoCheck module is designed to work with a | |
| quality control fluid system named AutoCheck 5+. The AutoCheck 5+ is | |
| an ampouled four level quality control fluid system. The composition of the | |
| various levels of Quality control fluids in AutoCheck 5+ correspond to the | |
| composition of the corresponding levels of Qualicheck 5+ system (K980135). |
The AutoCheck 5+ ampoules comprise a cap on the top of the ampoules
designed to break the top of an ampoule when it is to be used. Furthermore,
each ampoule has a bar code containing information on the specific level and
lot of the quality control fluid.
Installing an AutoCheck module into an existing ABL700 Series Analyzer
includes physically installing the module and loading upgraded software
which controls the function of the AutoCheck module. The AutoCheck
module comprises an ampoule carrousel carrying 20 ampoules of quality
control fluid and further comprises a bar code reader for reading the bar
code located on each ampoule. When installed into the ABL700 Series
Analyzer, the AutoCheck module automatically performs the quality control
of the analyzer. Thus, when a quality control is due, the analyzer warns the
user and if the user accepts, the quality control is performed. The software
selects the appropriate ampoule, the AutoCheck module opens the ampoule
by pressing the cap through the top of the ampoule, the quality control fluid
is automatically introduced into the analyzer inlet and the measurements are
performed. The upgraded software controls all steps. If required, a manual
quality control may be performed as well. |
1
RADIOMETER AMERICA INC.
| MEDICAL DIVISION | 810 SHARON DRIVE, WESTLAKE, OHIO 44145
800-736-0600, 440-871-8900
FAX 440-835-2633 |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The automatic inlet of sample loaded into a carrousel is a principle, which
is well known from various types of analyzers. Thus, it is well known in
coagulation and/or urine analyzers that the samples to be measured are
loaded with a sample carrousel. Also, the AVL9181 Electrolyte Analyzer
(K972673) for measuring electrolytes in i. a. whole blood, serum, or plasma
comprises a built-in autosampler. For further details of performing the
automatic quality control in the ABL700 Series Analyzer with the
AutoCheck module I refer to the enclosed sections of the Operator's
Manual. |
| INTENDED USE: | The ABL700 Series Analyzer with the AutoCheck module is a stand-alone
blood gas analyzer that measures pH, pCO2, pO2, cNa+, cK+, cCa2+, cCL-,
Glucose, Lactate, and Co-oximetry parameters on human arterial/venous
and capillary whole blood. The AutoCheck Module is an added
functionality to perform automated analysis of quality control fluids. |
| TECHNOLOGICAL
CHARACTERISTICS
VERSUS PREDICATE
DEVICE: | Similar to the ABL700 Series |
| SUBSTANTIAL
EQUIVALENCE: | The ABL700 Series Analyzer with the AutoCheck module is substantially
equivalent in features and characteristics to the current ABL700 Series
(K980130) marketed by Radiometer America Inc. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 0 2000
Mr. Vincent M. Sigmund Product Manager, Quality Services Radiometer America Inc. 810 Sharon Drive Westlake, Ohio 44145
K992859 Re:
Trade Name: ABL700 with AutoCheck Module Regulatory Class: II Product Code: CHL, JFP, CGZ, CGA, KHP, CEM, JGS, GKF Regulatory Class: I Product Code: JJS, KHP Dated: December 22, 1999 Received: December 23, 1999
Dear Mr. Sigmund:
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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 action. In addition, FDA may publish further announcements 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 regulations.
3
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine 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 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 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/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
4
EXHIBIT III
510(k) NUMBER (IF KNOWN): K992859
DEVICE NAME: ABL700 with AutoCheck Module
INDICATIONS FOR USE:
The ABL700 Series Analyzer with the AutoCheck module is a stand-alone blood gas analyzer that measures pH, pCO2, pO2, cNa*, cK+, cCa2+, cCL; Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood. The AutoCheck Module is an added functionality to perform automated analysis of quality control fluids.
Dan Cooper
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
(Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use Use (Per 21 CFR 801-109) Over-The-Counter-
(Optional Format 1-2-96)