This product is intended for use as an unassayed control material on the Abbott LCx Probe System with the Abbott Chlamydia Amplification Kit in the qualitative determination of Chlamydia trachomatis.

This product is intended to serve as an unassayed control material to monitor the analytical precision of the LCR amplification system incorporated in the Abbott LCx Probe System used in conjunction with the Abbott Chlamydia Amplification Kit. Response ratios (S/CO) have been set at appropriate positive (+) and negative (-) levels.

This product is intended for in vitro use only.

Device Description

The DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS Control is composed of plastic screw cap bottles, 2 mL each, containing two (2) levels of control, positive and negative, for Chlamydia trachomatis in a stabilized biological matrix. The formulation design provides a liquid matrix that is compatible with the Abbott Chlamydia Amplification Kit for assay on the LCx Probe System for the direct, qualitative determination of Chlamydia trachomatis.

AI/ML Overview

The provided text describes a 510(k) submission for a Chlamydia trachomatis control device and does not contain information about the acceptance criteria or a study demonstrating the device meets those criteria in the way a typical AI/medical device performance study would. It primarily focuses on the device's characteristics, intended use, and comparison to predicate devices for regulatory clearance.

However, I can extract the relevant information that would be considered "acceptance criteria" and "device performance" in the context of this regulatory submission, even if it's not a quantitative clinical study. For a control device, the "acceptance criteria" revolve around its functionality in a diagnostic system, and "performance" is demonstrated by its successful use with the specified assay.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a control device, the "acceptance criteria" are implied by its intended use and the "performance" is its functionality within the specified diagnostic system.

Acceptance Criterion (Implied)	Reported Device Performance
For Negative Control:
Is recognized as negative by the Abbott LCx Probe System with the Abbott Chlamydia Amplification Kit.	"Response ratios (S/CO) have been set at appropriate ... negative (-) levels."
Monitors analytical precision of the LCR amplification system.	Intended to "monitor the analytical precision of the LCR amplification system."
Performs as an unassayed negative control.	"Unassayed control intended for use with the Abbott Chlamydia Amplification Kit in the Abbott LCx Probe System for the direct, qualitative determination of Chlamydia trachomatis."
For Positive Control:
Is recognized as positive by the Abbott LCx Probe System with the Abbott Chlamydia Amplification Kit.	"Response ratios (S/CO) have been set at appropriate positive (+) ... levels."
Monitors analytical precision of the LCR amplification system.	Intended to "monitor the analytical precision of the LCR amplification system."
Performs as an unassayed positive control.	"Unassayed control intended for use with the Abbott Chlamydia Amplification Kit in the Abbott LCx Probe System for the direct, qualitative determination of Chlamydia trachomatis."
General Characteristics:
Volume: 2 mL	2 mL
Matrix: Stabilized biological matrix	Stabilized biological matrix
Dilution: None required	None required
Unopened Stability: 12 Months	Until Expiration Date 12 Months
Open Stability: 30 Days	30 Days
Compatible with Abbott Chlamydia Amplification Kit on LCx Probe System.	Designed for use with "Abbott Chlamydia Amplification Kit for assay on the LCx Probe System."

2. Sample size used for the test set and the data provenance

The document does not detail a specific "test set" in the context of a performance study with a defined sample size as would be expected for a diagnostic or AI device. Instead, the "testing" described is implicitly the characterization and verification of the control material's properties (stability, compatibility, intended response levels) in conjunction with the Abbott LCx system, likely performed during product development and validation by the manufacturer (CASCO Standards).

Sample Size: Not explicitly stated as a number of "cases" or "patients." It refers to levels of control material (positive and negative).
Data Provenance: The context suggests this is internal validation data generated by CASCO Standards in the US, used for regulatory submission. It is retrospective in the sense that the data was collected prior to the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept is not directly applicable to a control device like this one. For a control, the "ground truth" is inherent to the control's design and formulation (i.e., it is a positive control, it is a negative control). The performance is linked to whether the control behaves as expected within the validated diagnostic system. There are no "experts" establishing a disease state ground truth for individual samples.

4. Adjudication method for the test set

Not applicable. There's no "adjudication" in the sense of resolving discrepancies between human readers or reconciling different assessments of clinical cases. The performance is determined by the output of the LCx Probe System in response to the control material.

5. 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

Not applicable. This device is a diagnostic control, not an AI-powered diagnostic tool, and it does not involve human readers interpreting results in a clinical context that would necessitate an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to a standalone performance study for an algorithm. Not applicable, as this is a physical control material, not an algorithm. The "standalone" performance here refers to the control itself functioning correctly with the specified instrument system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this control device, the "ground truth" is defined by the composition and intended behavior of the control material itself. The negative control is formulated to be negative for Chlamydia trachomatis, and the positive control is formulated to elicit a positive response for Chlamydia trachomatis in the specified diagnostic system. This is an engineered ground truth, established during the design and manufacturing of the control. The predicate devices (Abbott LCx Chlamydia Negative Control and Human Urine Positive for Chlamydia trachomatis) serve as benchmarks for the expected performance.

8. The sample size for the training set

Not applicable. This device is a control material, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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. FEB 20 1998

510(k) Summary

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FEDERAL FOOD, DRUG AND COSMETIC ACT 510(k) SUMMARY DOCUMENT MÓLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL

1. Submitted by: CASCO Standards P.O. Box 970 Yarmouth, ME 04096
Christine V. Beach Attention: Manager, Regulatory Affairs

(207) 878-7550 (207) 878-7578 FAX

February 11,1998 (revision to June 27, 1997 submission)

2. Product Name:

DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS Proprietary Name: CONTROL

Classification Name: Control, single analyte, unassayed.

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3. Predicate Device:

Negative:

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Abbott LCx Chlamydia Negative Control

Positive

Urine, Human, Positive for Chlamydia trachomatis, as recommended in the package insert for the Abbott Chlamydia Amplification Kit.

The DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA 4. Product Description: TRACHOMATIS Control is composed of plastic screw cap bottles, 2 mL each, containing two (2) levels of control, positive and negative, for Chlamydia trachomatis in a stabilized biological matrix. The formulation design provides a liquid matrix that is compatible with the Abbott Chlamydia Amplification Kit for assay on the LCx Probe System for the direct, qualitative determination of Chlamydia trachomatis.

1. Intended Use: This product is intended for use with the Abbott Chlamydia Amplification Kit in the Abbott LCx Probe System for the direct, qualitative determination of Chlamydia trachomatis.

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11:47:

6. Comparison to the Predicate Device:

Characteristic	DOCUMENTMOLECULARPATHOLOGYCHLAMYDIATRACHOMATISNegative Control	Abbott LCxChlamydiaNegative Control	DOCUMENTMOLECULARPATHOLOGYCHLAMYDIATRACHOMATISPositive Control	Urine, HumanChlamydiatrachomatisPositive
Intended Use	Unassayed controlintended for usewith the AbbottChlamydiaAmplification Kit inthe Abbott LCxProbe System for thedirect, qualitativedetermination ofChlamydiatrachomatis	Automaticallyassessed by LCx,in conjunction withthe calibrator, todetermine thevalidity of theanalytical run	Unassayed controlintended for usewith the AbbottChlamydiaAmplification Kit inthe Abbott LCxProbe System forthe direct, qualitativedetermination ofChlamydiatrachomatis	N/A
Number of Levels	One (1)	One (1)	One (1)	N/A
Type	Negative	Negative	Positive	Positive
Analytes	1	1	1	N/A
Instrument Output	Rate	Rate	Rate	Rate
Measurement	S/CO Ratio	Instrument Pre-set	S/CO Ratio	S/CO Ratio
Volume	2 mL	0.48 ml	2 mL	N/A
Matrix	Stabilized biologicalmatrix	Buffered solution	Stabilized biologicalmatrix	N/A
Dilution	None required	Activation	None required	None required
Unopened Stability	Until Expiration Date12 Months	Until ExpirationDate	Until Expiration Date12 Months	N/A
Open Stability	30 Days	48 hrs. post-activation	30 Days	N/A

Image /page/2/Picture/6 description: The image is completely white and contains no discernible content. There are no objects, shapes, or patterns visible. The image appears to be a blank canvas.

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Image /page/3/Picture/12 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 0 1998

Christine V. Beach Manager, QA/RA CASCO Standards P.O. Box 970 Yarmouth, Maine 04096-1970

K972904 Re : R772901 Trachomatis Control Regulatory Class: I Product Codes: JJY 75, LSK 83 Dated: December 2, 1997 Received: December 5, 1997

Dear Ms. Beach:

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 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ৰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through ---periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 requlations.

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

Sincerely yours,

Steven Autman

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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510(k) Number : K972904

DOCUMENT® MOLECULAR PATHOLOGY CHLAMYDIA Device Name: TRACHOMATIS Control

Indications for Use:

This product is intended for use as an unassayed control material on the Abbott LCx Probe System with the Abbott Chlamydia Amplification Kit in the qualitative determination of Chlamydia trachomatis.

This product is intended for in vitro use only.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the -Counter Use - -

(Optional Format 1-2-96)

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.