(16 days)
Not Found
No
The summary describes calibrators and controls for an immunoassay system, which is a standard laboratory technique. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No
This device is for calibrating and quality control of an assay that quantifies dimeric Inhibin A levels, not for treating any condition.
No
Explanation: The device is described as "calibrators and controls" used to calibrate and monitor the performance of an assay, not to directly diagnose a condition. Its stated purpose is to calibrate an "Assay for the quantitative determination of dimeric Inhibin A levels", but calibrators and controls themselves do not provide a diagnosis.
No
The device description clearly states it is a kit containing bottles of calibrators and controls, which are physical substances used in an immunoassay system. This indicates a hardware component, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "quantitative determination of dimeric Inhibin A levels in human serum and plasma." This involves testing biological samples (serum and plasma) in vitro (outside the body) to obtain diagnostic information.
- Device Description: The description details the use of the calibrators and controls with an "Access Immunoassay System" and an "Immunoenzymatic method." These are standard techniques used in in vitro diagnostic testing.
- Performance Studies: The performance studies compare the device to a "predicate product" which is also an IVD (Diagnostic Systems Laboratories (DSL) ACTIVE® Inhibin A ELISA Calibrators and Controls, K002128). This comparison is a common requirement for demonstrating substantial equivalence for IVDs.
- Predicate Device: The listed predicate device is explicitly an IVD.
All these points strongly indicate that the Access Inhibin A calibrators and controls are intended for use in an in vitro diagnostic procedure.
N/A
Intended Use / Indications for Use
The Access Inhibin A calibrators are intended to calibrate the Access Inhibin A assay for the quantitative determination of dimeric Inhibin A levels in human serum and plasma using the Access Immunoassay Systems.
The Access Inhibin A QC is intended for monitoring system performance of the Access Inhibin A assay.
Product codes (comma separated list FDA assigned to the subject device)
JIT, JJX
Device Description
The Access Inhibin A Calibrators & Controls are designed for use with the Access Inhibin A Reagent for generation of the Inhibin A assay calibration curve on Beckman Coulter's Access immunoassay Systems. The Access Inhibin A Calibrator kit contains 7 X 2.5 mL bottles, one for each of seven calibrator levels. The Access Inhibin A Control kit contains 3 X 2.5 mL bottles, one for each of three control levels. The Access Immunoassay Systems utilize a competitive binding immunoenzymatic method for quantitative analyte measurement.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Access Inhibin A Calibrators have been demonstrated to be equivalent to the predicate product. Based on the results of the performance characteristics testing, these calibrator materials meet product claims and specifications.
Performance data from validation testing supports a finding of substantial equivalence to the Diagnostic Systems Laboratories (DSL) ACTIVE® Inhibin A ELISA Calibrators and Controls already in commercial distribution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
Not Found
§ 862.1150 Calibrator.
(a)
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.)(b)
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.
0
Access Inhibin A Calibrators & Controls 510(k) Summary
1.0 Submitted By:
Tyler Foutch Regulatory Affairs Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-1653 FAX: (952) 368-7610
2.0 Date Submitted
January 15, 2007
3.0 Device Name(s):
- 3.1 Proprietary Names
Access® Inhibin A Calibrators Access® Inhibin A Controls
3.2 Classification Names
Calibrator (21 CFR § 862.1150) Control (21 CFR § 862.1660)
4.0 Legally Marketed Device
The Access Inhibin A Calibrators & Controls claim substantial equivalence to the Diagnostic Systems Laboratories (DSL) ACTIVE® Inhibin A ELISA Calibrators and Controls currently in commercial distribution, FDA 510(k) Number K002128.
5.0 Device Description
The Access Inhibin A Calibrators & Controls are designed for use with the Access Inhibin A Reagent for generation of the Inhibin A assay calibration curve on Beckman Coulter's Access immunoassay Systems. The Access Inhibin A Calibrator kit contains 7 X 2.5 mL bottles, one for each of seven calibrator levels. The Access Inhibin A Control kit contains 3 X 2.5 mL bottles, one for each of three control levels. The Access Immunoassay Systems utilize a competitive binding immunoenzymatic method for quantitative analyte measurement.
FEB - 】2007
1
6.0 Intended Use
The Access Inhibin A calibrators are intended to calibrate the Access Inhibin A assay for the quantitative determination of dimeric Inhibin A levels in human serum and plasma using the Access Immunoassay Systems.
The Access Inhibin A QC is intended for monitoring system performance of the Access Inhibin A assay.
7.0 Comparison to the Predicate
The Access Inhibin A Calibrators and the predicate calibrator utilize different test methodologies, automated competitive binding immunoenzymatic method for the Access and manual ELISA method for the DSL. The Access Inhibin A calibrators and controls are provided in Bovine Serum Albumen, while the predicate calibrator and control are provided in Fetal Bovine Serum. Both are aligned to WHO international standard 91/624. Both devices come in a liquid solution format. The Access kit contains three controls while the predicate contains two controls. The measured range differs between the two devices, the Access assay range is 0-1500 pg/mL, while the predicate range is 0-1000 pg/mL
8.0 Summary of Performance Data
The Access Inhibin A Calibrators have been demonstrated to be equivalent to the predicate product. Based on the results of the performance characteristics testing, these calibrator materials meet product claims and specifications.
Performance data from validation testing supports a finding of substantial equivalence to the Diagnostic Systems Laboratories (DSL) ACTIVE® Inhibin A ELISA Calibrators and Controls already in commercial distribution.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three curved lines representing its wings or body. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Tyler Foutch Regulatory Affairs Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
FEB - 1 2007
Re: K070144
Trade/Device Name: Access Inhibin A Calibrators and QC Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, JJX Dated: January 15, 2007 Received: January 18, 2007
Dear Mr. Foutch:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
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) 276-0490. Also, please othe the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the from the (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean m. Cooper, M.S., D.V.M.
Sean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K070144
Device Name:_Access Inhibin A Calibrators and QC
Indications For Use:
The Access Inhibin A calibrators are intended to calibrate the Access Inhibin A assay for the quantitative determination of dimeric Inhibin A levels in human serum and plasma using the Access Immunoassay Systems.
The Access Inhibin A QC is intended for monitoring system performance of the Access Inhibin A assay.
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)
Carol C Benson
Vision Sign-Off
Office of In Vitro Diagnostic Device Braluation and Safety
Page 1 of ____________________________________________________________________________________________________________________________________________________________________