(45 days)
Not Found
No
The description focuses on the chemical composition and stability of a calibration product for a diagnostic test. There is no mention of AI or ML in the device description, intended use, or performance studies. The "automatically prepared and corresponding values calculated by the Dimension Vista™ System" likely refers to standard laboratory instrument automation and calculation, not AI/ML.
No.
This device is an in vitro diagnostic product designed for the calibration of a method used to detect Ecstasy on a specific system, not for therapeutic purposes.
No.
The device is a calibrator for an in vitro diagnostic product, not a diagnostic device itself. Its purpose is to calibrate the Ecstasy (EXTC) method on the Dimension Vista™ System, which is used for diagnostic testing.
No
The device is a liquid, human urine-based product containing chemical substances, which is a physical component, 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: "The EXTC CAL is an in vitro diagnostic product for the calibration of the Ecstasy (EXTC) method on the Dimension Vista™ System." This directly identifies the device as an IVD.
- Device Description: The description details a product used to calibrate a diagnostic test (Ecstasy method) performed on a sample (human urine) outside of the body ("in vitro").
- Purpose: The purpose of a calibrator in a diagnostic test is to establish a known relationship between the signal produced by the instrument and the concentration of the analyte (methylenedioxymethamphetamine in this case) in the patient sample. This is a fundamental component of an in vitro diagnostic process.
N/A
Intended Use / Indications for Use
The EXTC CAL is an in vitro diagnostic product for the calibration of the Ecstasy (EXTC) method on the Dimension Vista™ System.
Product codes (comma separated list FDA assigned to the subject device)
DLJ
Device Description
EXTC CAL is a liquid, human urine-based product containing weighed-in quantities of methylenedioxymethamphetamine. The kit consists of six vials, three vials of Calibrator A and three vials of Calibrator B. EXTC CAL is ready for use (no preparation is required). The volume per vial is 2.3 mL. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.
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
Not Found
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)
Stability:
Target shelf life for the Dimension Vista™ System Ecstasy Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4℃ with control stored at -20℃. The method is calibrated from this stored material. The 4℃ material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined where the allowable shelf life percent change is ≤ 10 %. Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.
A vial punctured by the instrument and stored on board is stable for 24 hours.
An open vial not on instrument, but recapped and stored in a refrigerator is stable for 31 days.
For testing, vials are opened /punctured on day zero. A quantity sufficient for multiple calibrations is removed and the vials are recapped and stored at 2 - 8 °C. Opened/punctured vials are tested on days 0, 1, 2, and 8 and opened vials are also tested at 32 days versus freshly opened vials.
Traceability:
The assigned values of the ECTX CAL is traceable to Methylenedioxymethamphetamine (99% purity) (Cerilliant, Inc., 811 Paloma Drive, suite A, Roundrock, TX 78664.
Value Assignment:
The new calibrator Master Pool is made by adding weighed quantities of Methylenedioxymethamphetamine Reference Material to drug free human urine. Five levels of Master Pool are prepared and stored at -70° C. The Master Pool values are verified against the values of a previously approved Master Pool lot and Gas Chromatography / Mass Spectrometry (GC/MS) testing.
A stock solution is prepared for the new commercial calibrator lot by gravimetrically adding Methylenedioxymethamphetamine to stock solution at target concentration. The stock solution concentration is verified by comparing them to the Master Pool assigned bottle values.
For the commercial calibrator lot, calculated quantity of the stock solution is added to drug free human urine to target concentrations for two calibrator levels. The concentration of each level of the commercial lot is verified to be within acceptable range by using an instrument calibrated with Master Pools and by GC/MS testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
510(k) Summary for the Dimension Vista™ System Ecstasy Calibrator (EXTC CAL - KC520)
SEP 1 4 2006
A. 510(k) Number:
| B. Analyte: | Ecstasy (EXTC) |
|---|---|
| C. Type of Test: | Calibrator Material |
| D. Applicant: | Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101 |
| Victor M. Carrio, Regulatory Affairs and Compliance Manager | |
| Office: (302) 631-0376 Fax: (302) 631-6299 |
E. Proprietary and Established Names:
Dimension Vista™ System Ecstasy Calibrator (EXTC CAL - KC520)
F. Regulatory Information:
-
- Regulation section: 21 CFR § 862.3200 Clinical toxicology calibrator
-
- Classification: Class II
-
- Product Code: DLJ Calibrator, Drug Specific
-
- Panel: Toxicology
- G. Intended Use: The EXTC CAL is an in vitro diagnostic product for the calibration of the Ecstasy (EXTC) method on the Dimension Vista™ System.
H. Device Description:
EXTC CAL is a liquid, human urine-based product containing weighed-in quantities of methylenedioxymethamphetamine. The kit consists of six vials, three vials of Calibrator A and three vials of Calibrator B. EXTC CAL is ready for use (no preparation is required). The volume per vial is 2.3 mL. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.
1
I. Substantial Equivalence Information:
-
- Predicate Device: SYVA® EMIT® II Plus Ecstasy Calibrators/Controls cleared under K043028.
-
- Comparison with Predicate:
| New Device | Predicate Device | |
|---|---|---|
| Item | Dimension Vista™ System | |
| Ecstasy Calibrator | SYVA® EMIT® II Plus Ecstasy | |
| Calibrators/Controls | ||
| (K043028) | ||
| Intended Use | The EXTC CAL is an in vitro | |
| diagnostic product for the | ||
| calibration of the Ecstasy (EXTC) | ||
| method on the Dimension Vista™ | ||
| System. | The Emit® II Plus Ecstasy Calibrators/Controls | |
| are used in the calibration of the Emit® II Plus | ||
| Ecstasy Assay. These standards may also be used | ||
| as quality control materials based on the specific | ||
| Ecstasy Assay cutoff. | ||
| Analytes | Methylenedioxymethamphetamine. | Methylenedioxymethamphetamine |
| Form | Liquid. | Liquid. |
| Traceability | Methylenedioxymethamphetamine | |
| (99% purity) (Cerilliant)a. | Methylenedioxymethamphetamine (MDMA) | |
| Matrix | Human urine. | Human urine. |
| Calibration / | ||
| Verification | ||
| Levels | Two levelsb. | Four levels. |
ªCerilliant Inc., 811 Paloma Drive, suite A, Roundrock, TX 78664.
· Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.
J. Standard/Guidance Document Referenced:
| 1. Guidance: | Guidance for Industry - Abbreviated 510(k) Submissions for In
Vitro Diagnostic Calibrators; Final, 02/22/1999
Guidance for Industry and FDA Staff - Use of Symbols on Labels
and in Labeling of In Vitro Diagnostic Devices Intended for
Professional Use, 11/30/2004 |
| -------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
-
- Standards: CEN 13640 Stability testing of In-Vitro Diagnostic Devices ISO 14971:2000 Medical devices -Application of risk management to medical devices
K. Performance Characteristics:
-
- Stability: Target shelf life for the Dimension Vista™ System Ecstasy Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4℃ with control stored at -20℃. The method is calibrated from this stored material. The 4℃ material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is
2
determined where the allowable shelf life percent change is ≤ 10 %. Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.
A vial punctured by the instrument and stored on board is stable for 24 hours.
An open vial not on instrument, but recapped and stored in a refrigerator is stable for 31 days,
For testing, vials are opened /punctured on day zero. A quantity sufficient for multiple calibrations is removed and the vials are recapped and stored at 2 - 8 °C. Opened/punctured vials are tested on days 0, 1, 2, and 8 and opened vials are also tested at 32 days versus freshly opened vials.
- Traceability: The assigned values of the ECTX CAL is traceable to Methylenedioxymethamphetamine (99% purity) (Cerilliant, Inc., 811 Paloma Drive, suite A, Roundrock, TX 78664.
-
- Value Assignment:
The new calibrator Master Pool is made by adding weighed quantities of Methylenedioxymethamphetamine Reference Material to drug free human urine. Five levels of Master Pool are prepared and stored at -70° C. The Master Pool values are verified against the values of a previously approved Master Pool lot and Gas Chromatography / Mass Spectrometry (GC/MS) testing.
- Value Assignment:
A stock solution is prepared for the new commercial calibrator lot by gravimetrically adding Methylenedioxymethamphetamine to stock solution at target concentration. The stock solution concentration is verified by comparing them to the Master Pool assigned bottle values.
For the commercial calibrator lot, calculated quantity of the stock solution is added to drug free human urine to target concentrations for two calibrator levels. The concentration of each level of the commercial lot is verified to be within acceptable range by using an instrument calibrated with Master Pools and by GC/MS testing.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 4 2006
Mr. Victor Carrio Dade Behring, Inc. P.O. Box 6101 Newark, DE 6101
Re: K062182
Trade/Device Name: Dimension Vista™ System Ectasy Calibrator Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DLJ Dated: July 28, 2006 Received: July 31, 2006
Dear Mr. Carrio:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Guti
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications For Use Statement
510(k) Number (if known):
Device Name:
Dimension Vista™ System Ecstasy Calibrator (EXTC CAL - KC520)
Indications for Use:
The EXTC CAL is an in vitro diagnostic product for the calibration of the Ecstasy (EXTC) method on the Dimension Vista™ System.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)
월 20일 중국 지문서쌍 % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % %
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
K06218