(60 days)
No
The document describes a chemical calibrator for a clinical chemistry system, with no mention of AI or ML in its function or description.
No.
The device is an in vitro diagnostic product intended for calibrating methods for a clinical chemistry system, not for direct therapeutic intervention on a patient.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Drug Calibrator II is an in vitro diagnostic product..." and discusses its use in the "measurement of human substances," which directly relates to diagnostics.
No
The device description clearly states it is a "liquid product" and a "kit consists of ten vials," indicating it is a physical, in vitro diagnostic product, 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: "Drug Calibrator II is an in vitro diagnostic product intended for use in an in vitro test system..."
- Function: The device is used to calibrate methods for measuring human substances (Acetaminophen, Carbamazepine, Gentamicin, Tobramycin, Valproic Acid, and Vancomycin) within a clinical chemistry system. This is a core function of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Drug Calibrator II is intended to be used to calibrate the Acetaminophen (ACTM), Carbamazepine (CRBM), Gentamicin (GENT), Tobramycin (TOBR), Valproic Acid (VALP), and Vancomycin (VANC) methods for the Dimension® clinical chemistry system.
Drug Calibrator II is an in vitro diagnostic product intended for use in an in vitro test system to establish points of reference that are used in the determination of values in the measurement of human substances.
Product codes
DKB
Device Description
Drug Calibrator II (K962817) is being modified to add valproic acid as an additional constituent on the product labeling. Drug Calibrator II is a liguid product. Level 1 is bovine albumin. Levels 2 through 5 contain acetaminophen, carbamazepine, gentamicin, tobramycin, valproic acid and vancomycin in a bovine albumin base. The kit consists of ten vials; two at each of five levels, containing 5 mL each.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Drug Calibrator II (K962817)
Reference Device(s)
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
1982871
DADE BEHRING
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | Rebecca S. Ayash
Dade Behring Inc.
Building 500, Mailbox 514
P.O. Box 6101
Newark, DE 19714-6101 |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | 8/13/98 |
| Device Name: | Drug Calibrator II |
| Classification Name: | Calibrator, Drug Mixture |
| Predicate Device: | Drug Calibrator II (K962817) |
Device Description: Drug Calibrator II (K962817) is being modified to add valproic acid as an additional constituent on the product labeling. Drug Calibrator II is a liguid product. Level 1 is bovine albumin. Levels 2 through 5 contain acetaminophen, carbamazepine, gentamicin, tobramycin, valproic acid and vancomycin in a bovine albumin base. The kit consists of ten vials; two at each of five levels, containing 5 mL each.
Intended Use: Drug Calibrator II is intended to be used to calibrate the Acetaminophen (ACTM), Carbamazepine (CRBM), Gentamicin (GENT), Tobramycin (TOBR), Valproic Acid (VALP), and Vancomycin (VANC) methods for the Dimension® clinical chemistry system.
Comparison to Predicate Device:
| Drug Calibrator II | Drug Calibrator II (Modified) | |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analyte | Acetaminophen, carbamazepine, | |
| gentamicin, tobramycin, | ||
| vancomycin | Acetaminophen, carbamazepine, | |
| gentamicin, tobramycin, valproic acid, | ||
| vancomycin | ||
| Matrix | Bovine albumin | Bovine albumin |
| Form | Liquid | Liquid |
| Volume | 5.0 mL per vial | 5.0 mL per vial |
| Levels | 5 levels | 5 levels |
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Comments on Substantial Equivalence: Drug Calibrator II (modified) is the same product as the product currently marketed (K962817) with the only difference being revision of the labeling to add the constituent valproic acid. Both products are intended to be used as calibrators for drug assays.
Conclusion: Drug Calibrator II (modified) is substantially equivalent to the currently marketed Drug Calibrator II based on the comparison summarized above.
Rebecca S. Cayton
Rebecca S. Avash Regulatory Affairs and Compliance Manager Date: 8/13/98
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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The seal is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 3 1998
Rebecca S. Ayash Regulatory Affairs and Compliance Manger Dade Behring, Inc. Glasgow Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101
Re : K982871 Drug Calibrator II Regulatory Class: II Product Code: DKB Dated: August 13, 1998 Received: August 14, 1998
Dear Ms. Ayash:
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 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 Requlations, Title 21, Parts 800 to 895. ਕਿ 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 leqally 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/dsmamain.html".
Sincerely yours,
Steven Butman
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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Indications Statement
Device Name: Drug Calibrator II
Indications for Use: Drug Calibrator II is an in vitro diagnostic product intended for use in an in vitro test system to establish points of reference that are used in the determination of values in the measurement of human substances. ---
Rebecca Slenysh
Rebecca S. Ayash Regulatory Affairs and . Compliance Manager Date: 8/13/98
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
Division Sign-Off Office of Device Evaluation