The Beckman Coulter OP 300 Low and High Urine Controls, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for monitoring the quality control for OP 300 ng in the clinical laboratory.

Device Description

The SYNCHRON® Systems OP 300 Low and High Urine Controls are intended for use on SYNCHRON Systems for the quality control of Opiate 300 ng. This product contains a 5.0 mL bottle of the Low Urine Control and a 5.0 mL bottle of the High Urine Control. The storage temperature for the calibrators is +2℃ to +8℃.

The SYNCHRON® Systems OP Low and High Urine Controls are ready-to-use human, urine-based, liquid controls. They are derived by adding known quantities (traceable to Gas Chromatography/Mass Spectrometry) of morphine (for opiate) to human urine to achieve each drug analyte concentration.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device: SYNCHRON® Systems OP 300 Low and High Urine Controls. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a comprehensive study report proving the device meets those criteria in the way a new, de novo device might.

Therefore, many of the requested fields cannot be directly answered from this regulatory submission. However, I can extract the available information and explain why other fields are not present.

Acceptance Criteria and Device Performance

Acceptance Criterion	Reported Device Performance	Comments
Preamble of Substantial Equivalence	The device is substantially equivalent to legally marketed predicate devices.	This is the overarching "acceptance criterion" for a 510(k) submission.
Opiate Level Identity	The opiate level between the candidate and predicate product is identical. Both contain 300 ng and 1000 ng opiate (morphine) analyte.	This is a key point of comparison for substantial equivalence.
Material Basis	Both candidate and predicate are human, urine-based, ready-to-use liquid calibrators.	Another key comparison point.
Stability Claim	Stress stability studies support an 18-month stability claim.	This is a performance claim made by the manufacturer and is supported by internal data, suggesting the device met a stability criterion. The specific acceptance criteria (e.g., within X% of initial value after 18 months) are not detailed.

Detailed Study Information (Based on availability in the document):

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "stress stability studies" and "performance data" but does not quantify the number of samples or runs.
- Data Provenance: Not explicitly stated, though it would be internal Beckman Coulter data as part of their product development and validation process. The country of origin of the data is not mentioned, but the company is US-based. It would be prospective data generated during product development.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable or not stated. For an IVD control, "ground truth" is typically established by the manufacturing process itself (i.e., known concentrations of analytes), and verified by internal quality control and analytical methods. Expert consensus in the traditional sense (e.g., radiologists interpreting images) is not relevant for this type of device.
- Qualifications of Experts: Not applicable.
Adjudication method for the test set:
- Not applicable/Not stated. Adjudication methods like 2+1 or 3+1 are typically for subjective interpretations, such as clinical image analysis. For an IVD control, the "ground truth" is analytical (known concentration), and performance is assessed against this known value using predetermined analytical methods.
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:
- No, an MRMC study was not done. This type of study is completely irrelevant for an in vitro diagnostic control. These controls are used to monitor the performance of analytical instruments (SYNCHRON Systems), not to assist human interpretation of medical images or data in the way AI algorithms do.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is based on the assumption of an AI/algorithm-driven device. The SYNCHRON® Systems OP 300 Low and High Urine Controls are reagents/controls for an analytical instrument. Their "performance" is their ability to perform consistently with known values over their claimed shelf life, within analytical specifications. The concept of "standalone performance" for an algorithm does not apply here. The device itself is the "standalone" control, whose performance is measured by the instrument it is used with.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for these controls is the known, analytically determined concentration of morphine added to the human urine matrix. The document states: "They are derived by adding known quantities (traceable to Gas Chromatography/Mass Spectrometry) of morphine (for opiate) to human urine to achieve each drug analyte concentration." This indicates a highly analytical and quantitative method for establishing the "truth."
The sample size for the training set:
- Not applicable/Not stated. This device is not an AI/ML algorithm that requires a "training set." It is a chemical control product.
How the ground truth for the training set was established:
- Not applicable (no training set for this type of device). However, as noted in point 6, the ground truth (known concentration) for the manufactured product batches is established through precise addition of analytes, traceable to reference methods like Gas Chromatography/Mass Spectrometry (GC/MS).

Summary

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NOV 26 1999

K993023

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Summary of Safety and Effectiveness SYNCHRON® Systems OP 300 Low and High Urine Controls

1.0 Submitted By:

Gail Lefebvre Associate Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 993-8503 FAX: (714) 961-4123

2.0 Date Submitted . .

September 7, 1999

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Systems OP 300 Low and High Urine Controls

3.2 Classification Name

Clinical Toxicology Control (21 CFR § 862.3280)

4.0 Predicate Device(s):

SYNCHRON SystemsReagent	Predicate	Manufacturer	DocketNumber
SYNCHRON® SystemsOP 300 Low and HighUrine Controls	SYNCHRON® SystemsDAT Low and HighUrine Controls II	Beckman Coulter, Inc.	K983748

5.0 Description:

Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

Telephone: (714) 993-5321 Facsimile: (714) 961-4165 Internet: www.beckmancoulter.com

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6.0 Intended Use:

7.0 Comparison to Predicate(s):

The opiate level between the two products is identical. Both the candidate and the predicate are human, urine-based, ready-to-use liquid calibrators with 300 ng and 1000 nq opiate (morphine) analyte added.

8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to toxicology controls already in commercial distribution. Stress stability studies of the OP 300 Low and High Urine Controls support the Beckman stability claim of 18 months.

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 26 1999

Ms. Gail Lefebvre Associate Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard, W-104 Box 8000 Brea, California 92822-8000

K993023 Re:

Trade Name: SYNCHRON® Systems OP 300 Low and High Urine Controls Regulatory Class: I Product Code: JJY Dated: September 7, 1999 Received: September 9, 1999

Dear Ms. Lefebvre:

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 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.

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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K993023

Device Name: SYNCHRON® Systems OP 300 Low and High Urine Controls

Indications for Use:

The Beckman Coulter OP 300 Low and High Urine Controls, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for monitoring the quality control for Opiate 300 ng in the clinical laboratory.

Clinical Significance:

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Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K993023

Prescription Use (per 21 CFR 801.109)	OR	Over-the-Counter Use Optional Format 1-2-96
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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.