(198 days)
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No
The document describes a control material for a molecular diagnostic test and does not mention any AI or ML components.
No
The device is described as an "unassayed control material" for an amplification system used in the qualitative determination of Chlamydia trachomatis, and is intended "for in vitro use only." It is not directly applied to a patient for diagnosis, treatment, or prevention of disease.
No
This device is described as an "unassayed control material" intended to "monitor the analytical precision" of an amplification system, not to directly diagnose a condition in a patient. It is used to verify the performance of a diagnostic test, rather than performing the diagnosis itself.
No
The device description explicitly states it is composed of "plastic screw cap bottles" containing "stabilized biological matrix," indicating it is a physical control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the 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 clearly indicates its use in a laboratory setting to analyze biological samples for diagnostic purposes.
- "in vitro use only": The "Intended Use / Indications for Use" section also explicitly states "This product is intended for in vitro use only." This is a key characteristic of IVD devices, meaning they are used outside of a living organism.
- Device Description: The description details a control material used with a specific diagnostic system (Abbott LCx Probe System and Abbott Chlamydia Amplification Kit) for the determination of Chlamydia trachomatis. This further supports its role in an in vitro diagnostic process.
- Predicate Device: The mention of a "Predicate Device" which is also a control material for Chlamydia trachomatis on the same system reinforces that this device falls within the category of IVDs used in conjunction with other diagnostic components.
Therefore, based on the provided information, this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
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.
Product codes
JJY 75, LSK 83
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Abbott LCx Chlamydia Negative Control, Urine, Human, Positive for Chlamydia trachomatis, as recommended in the package insert for the Abbott Chlamydia Amplification Kit.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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. FEB 20 1998
510(k) Summary
10:11
FEDERAL FOOD, DRUG AND COSMETIC ACT 510(k) SUMMARY DOCUMENT MÓLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL
-
- 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:
10:11
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.
-
- 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.
2
11:47:
6. Comparison to the Predicate Device:
| Characteristic | DOCUMENT
MOLECULAR
PATHOLOGY
CHLAMYDIA
TRACHOMATIS
Negative Control | Abbott LCx
Chlamydia
Negative Control | DOCUMENT
MOLECULAR
PATHOLOGY
CHLAMYDIA
TRACHOMATIS
Positive Control | Urine, Human
Chlamydia
trachomatis
Positive |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Intended Use | 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 | Automatically
assessed by LCx,
in conjunction with
the calibrator, to
determine the
validity of the
analytical run | 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 | 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 biological
matrix | Buffered solution | Stabilized biological
matrix | N/A |
| Dilution | None required | Activation | None required | None required |
| Unopened Stability | Until Expiration Date
12 Months | Until Expiration
Date | Until Expiration Date
12 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
5
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 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.
(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)
OR
Over-the -Counter Use - -
(Optional Format 1-2-96)