(25 days)
K 981864
Not Found
No
The summary describes a quality control material for an immunoassay system, which is a chemical reagent used for calibration and monitoring, not a device that processes data or images using AI/ML.
No
Explanation: The device is described as a quality control material intended for monitoring the performance of an immunoassay system in a clinical laboratory. It is not used for treating or diagnosing any conditions.
No
Explanation: The device is a quality control material used to monitor the performance of an immunoassay system. It does not directly diagnose disease or provide medical information about a patient.
No
The device description explicitly states it is a "bi-level ready-to-use defined protein-based liquid control," indicating it is a physical reagent, not software.
Based on the provided information, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the reliability and overall performance of the Access Ostase Immunoassay system in the clinical laboratory." This is a classic function of an IVD control material, which is used to verify the performance of an IVD assay.
- Device Description: It describes the device as "bi-level ready-to-use defined protein-based liquid controls." Control materials used in laboratory testing fall under the umbrella of IVDs.
- Predicate Device: The mention of a predicate device (K 981864; Access AFP QC) which is also a QC material, further supports its classification as an IVD. Predicate devices are used to demonstrate substantial equivalence for regulatory purposes, and they are typically in the same regulatory category.
While the document doesn't contain information about image processing, AI, patient age, or performance studies (which are often associated with more complex IVDs), the core function and description clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Beckman Coulter's Access Ostase QC is intended for use in monitoring the reliability and overall performance of the Access Ostase Immunoassay system in the clinical laboratory. The use of control materials allow the laboratorian to monitor linearity along with analytical error and imprecision.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Access Ostase QC are bi-level ready-to-use defined protein-based liquid controls manufactured by Beckman Coulter, Inc. Each kit contains 1 X 4 mL bottles for each level of control.
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
clinical laboratory
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)
Not Found
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.
K 981864
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
§ 862.1660 Quality control material (assayed and unassayed).
(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
JAN 1 4 2000
Summary of Safety & Effectiveness Access Ostase QC
1.0 Submitted By:
Mara Caler Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 7330 Carroll Road P.O. Box 269006 San Diego, CA 92196-9006 Telephone: (619) 621-4583 FAX: (619) 621-4752
2.0 Date Submitted:
December 15, 1999
3.0 Device Name(s):
3.1 Proprietary Names
Access Ostase QC
3.2 Classification Name
Quality Control Material (assayed and unassayed) (21 CFR § 862.1660)
3.3 Device Classification
Class I (low risk)
4.0 Predicate Device(s):
| BECKMAN
COULTER Reagent | Predicate | Predicate Company | Docket
Number |
|----------------------------|------------------|----------------------|------------------|
| Access Ostase QC | Access
AFP QC | Beckman Coulter Inc. | K 981864 |
1
5.0 Description:
The Access Ostase QC are bi-level ready-to-use defined protein-based liquid controls manufactured by Beckman Coulter, Inc. Each kit contains 1 X 4 mL bottles for each level of control.
6.0 Intended Use:
Beckman Coulter's Access Ostase QC is intended for use in monitoring the reliability and overall performance of the Access Ostase Immunoassay system in the clinical laboratory. The use of control materials allow the laboratorian to monitor linearity along with analytical error and imprecision.
2
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 stylized eagle or bird symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
JAN 1 4 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Mara Caler Regulatory Specialist Beckman Coulter, Inc. P.O. Box 269006 7330 Carroll Road San Diego, California 92196-9006
Re: K994277 Trade Name: Access® Ostase® OC Regulatory Class: I reserved Product Code: JJX Dated: December 15, 1999 Received: December 20, 1999
Dear Ms. Caler:
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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.
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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
K994277 510(k) Number (if known): Not yet assigned
Device Name: Access® Ostase® QC
Indications for Use:
Beckman Coulter's Access Ostase QC is intended for use in monitoring the reliability and overall performance of the Access Ostase Immunoassay system in the clinical laboratory. The use of control materials allow the laboratorian to monitor linearity along with analytical error and imprecision.
21 CFR 862.1660 Quality Control Material (assayed and unassayed)
(a) 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 studies 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 urinalvsis controls.
(b) Classification. Class I.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory
510(k) Number K994277
| Prescription Use
(per 21 CFR 801.109) | | OR | Over-the-Counter Use
Optional Format 1-2-96 |
| ------------------------------------------ | ------------------------------------ | ---- | ------------------------------------------------ |
|---|
Beckman Coulter Inc., Section 510(k) Notification Access® Ostase® QC AccessOstaseQC/Ostase510(k)sec1.doc
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