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.

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.

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those acceptance criteria. It primarily focuses on the submission details, regulatory classification, and intended use of the Access Ostase QC device.

However, based on the general understanding of Quality Control Materials for in vitro diagnostics, I can infer the likely nature of such a study and the potential acceptance criteria, though the specific values are not present in the document.

Here's a breakdown of what can be extracted and what needs to be inferred for a Quality Control Material like "Access Ostase QC":

Inferred Acceptance Criteria and Reported Device Performance (as typically expected for QC materials):

Acceptance Criteria Category	Typical Acceptance Criteria for QC Material (Inferred)	Reported Device Performance (Not found in provided text)
Accuracy (Trueness)	Mean measured value of the QC material falls within a pre-defined range of the target/assigned value (e.g., +/- X% of the target value for each level).	Specific mean measured values and their deviation from target values for Level 1 and Level 2 would be reported.
Precision (Repeatability/Within-Run)	Coefficient of Variation (CV%) for replicate measurements of the QC material is below a specified threshold (e.g., < 5% CV for each level).	Specific CV% values for Level 1 and Level 2 under repeatability conditions would be reported.
Precision (Reproducibility/Between-Run)	Coefficient of Variation (CV%) for measurements across multiple runs/days is below a specified threshold (e.g., < 10% CV for each level).	Specific CV% values for Level 1 and Level 2 under reproducibility conditions would be reported.
Stability	QC material maintains its assigned values within specified acceptance limits over its claimed shelf-life and in-use stability periods.	Data demonstrating stability over time, temperature variations, and freeze-thaw cycles (if applicable) would be provided.
Lot-to-Lot Consistency	Different manufacturing lots of the QC material yield comparable results within pre-defined acceptance limits when tested on the same system.	Data comparing performance across multiple manufacturing lots would be provided.
Homogeneity	The QC material is uniform throughout the bottle, ensuring consistent results regardless of the aliquot taken.	Data demonstrating homogeneity within a bottle would be provided.

Since the provided document is a 510(k) summary for a Class I device (Quality Control Material), it typically focuses on substantial equivalence rather than presenting a full performance study with detailed acceptance criteria and results. The key information for a Class I device like this is that it performs its intended function (monitoring reliability and performance of an immunoassay system) similarly to an already legally marketed equivalent device (the predicate device).

Regarding the specific questions:

A table of acceptance criteria and the reported device performance: As shown above, this information is not present in the provided text. The document states "Beckman Coulter's Access Ostase QC is intended for use in monitoring the reliability and overall performance of the Access Ostase Immunoassay system... The use of control materials allow the laboratorian to monitor linearity along with analytical error and imprecision." This describes the purpose relevant to performance, but not the quantitative criteria or results.
Sample size used for the test set and the data provenance: This information is not provided in the text. For a QC material, a "test set" would typically refer to a series of runs or measurements performed to establish its performance characteristics (accuracy, precision, stability). No details on the number of samples, runs, or laboratories are given. The provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable in the traditional sense for a Quality Control Material. For a QC material, the "ground truth" or "assigned values" are typically established through extensive testing by the manufacturer, possibly in comparison to reference methods or through value assignment protocols using multiple instruments/laboratories, not directly by "experts" reviewing individual cases.
Adjudication method for the test set: This is not applicable for a Quality Control Material. Adjudication methods (like 2+1, 3+1) are used in diagnostic studies where multiple human readers assess cases, and their opinions need to be reconciled to establish a consensus ground truth. For QC materials, performance is assessed through quantitative measurements against established statistical criteria.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not applicable to this device. An MRMC study is relevant for diagnostic devices (often imaging AI) where human performance is compared with and without AI assistance on a set of clinical cases. The Access Ostase QC is a quality control material, not a diagnostic device that assists human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This is not applicable to this device. "Standalone performance" refers to the performance of an algorithm or diagnostic device without human intervention. The Access Ostase QC is a physical reference material used by a laboratorian with an immunoassay system, not an algorithm.
The type of ground truth used: For a Quality Control Material, the "ground truth" refers to its assigned value(s). These values are typically established through:
- Value Assignment Studies: Extensive testing by the manufacturer using calibrated reference methods or multiple qualified instruments/laboratories to determine target values and acceptable ranges for the control material.
- Traceability: Often, the assigned values are made traceable to reference materials or a higher-order measurement procedure.
  The document itself does not specify the method for establishing "ground truth" for the assigned values of the Access Ostase QC.
The sample size for the training set: This is not applicable as the Access Ostase QC is not an AI/ML algorithm that requires a "training set." It is a physical quality control material.
How the ground truth for the training set was established: This is not applicable as there is no "training set" for this device.

Summary

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JAN 1 4 2000

K994277

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):

BECKMANCOULTER Reagent	Predicate	Predicate Company	DocketNumber
Access Ostase QC	AccessAFP QC	Beckman Coulter Inc.	K 981864

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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:

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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

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K994277 510(k) Number (if known): Not yet assigned

Device Name: Access® Ostase® QC

Indications for Use:

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)

signature
(Division Sign-Off)
Division of Clinical Laboratory

510(k) Number K994277

Prescription Use(per 21 CFR 801.109)		OR	Over-the-Counter UseOptional Format 1-2-96
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Beckman Coulter Inc., Section 510(k) Notification Access® Ostase® QC AccessOstaseQC/Ostase510(k)sec1.doc

Section 1 Page 18

Regulation Number and Section

§ 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.