(55 days)
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No
The device description details a standard enzyme immunoassay based on chemical reactions and spectrophotometric measurement. There is no mention of AI, ML, or any computational algorithms beyond basic data processing for absorbance measurements. The performance study compares the assay results to HPLC, a traditional analytical method, further indicating the absence of AI/ML.
No
The device is used for quantitative analysis of caffeine levels, which aids in monitoring therapy but does not directly provide therapeutic benefits or treat a disease.
Yes
The device quantifies caffeine levels in human serum to assist in managing therapy, which directly supports diagnosis and monitoring of patient conditions.
No
The device description clearly outlines a homogeneous enzyme immunoassay technique involving chemical reactions, enzyme activity measurement, and spectrophotometric analysis, which are all hardware-dependent processes.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative analysis of caffeine levels in human serum." This involves testing a biological sample (human serum) outside of the body to provide information about a patient's health status (caffeine levels in this case).
- Device Description: The description details a "homogeneous enzyme immunoassay technique used for the analysis of specific compounds in biological fluids." This is a common method used in IVD devices to measure substances in samples like serum.
- Sample Type: The assay is performed on "human serum," which is a biological fluid.
- Performance Study: The performance study involves testing "neonate samples" and comparing the results to another analytical method (HPLC). This is typical for validating the performance of an IVD device.
All of these characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
The Emit® Caffeine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of caffeine levels in human serum in subjects undergoing therapy with caffeine, especially in cases of neonatal apnea.
Product codes (comma separated list FDA assigned to the subject device)
91 KLS
Device Description
The Emit® Caffeine Assay is a homogeneous enzyme immunoassay technique used for the analysis of specific compounds in biological fluids. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate deyhdrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH. resulting in an absorbance change that can be measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.
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
neonatal
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
To support the broader intended use, a method comparison study was performed using 110 neonate samples with values spanning the assay range. Of these samples, thirty-one (31) were from patients who had received Theophylline and 79 were from patients who had received with Caffeine. The Assay results were compared to HPLC.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The modified Emit® Caffeine Assay has a broader intended use than the currently cleared Emit® Caffeine Assay to include measurement of caffeine as a parent drug. The use of the current Emit® Caffeine Assav is limited to measurement of caffeine as a metabolite of Theophylline. To support the broader intended use, a method comparison study was performed using 110 neonate samples with values spanning the assay range. The Emit® Caffeine Assay had excellent correlation with HPLC (correlation coefficient=0.99). Other performance characteristics of the Emit® Caffeine Assay were previously established under K853872.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient=0.99
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.
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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).
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§ 862.3880 Theophylline test system.
(a)
Identification. A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.(b)
Classification. Class II.
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510(k) Summary Emit® Caffeine Assay
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.
The assigned 510(k) number is: K042407
Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation
| Manufacturer: | Dade Behring Inc.
20400 Mariani Ave.
Cupertino, CA 95014 |
|----------------------|-----------------------------------------------------------------------------------------------------|
| Contact Information: | Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714
Attn: Yuk-Ting Lewis
Tel: 302-631-7626 |
| Date of Preparation: | October 18, 2004 |
Device Name / Classification 2.
Emit® Caffeine Assay / Enzyme immunoassay, Theophylline
Product code: 91 KLS
3. Identification of the Legally Marketed Device
Emit® Caffeine Assay - K853872
4. Device Description
The Emit® Caffeine Assay is a homogeneous enzyme immunoassay technique used for the analysis of specific compounds in biological fluids. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate deyhdrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH. resulting in an absorbance change that can be measured spectrophotometrically.
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Endogenous serum G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.
5. Device Intended Use
The Emit® Caffeine Assay is a homoqeneous enzyme immunoassay intended for use in the quantitative analysis of caffeine levels in human serum in subjects underqoing therapy with caffeine, especially in cases of neonatal apnea.
6. Medical device to which equivalence is claimed and comparison information
The modified Emit® Caffeine Assay has a broader intended use than the currently cleared Emit® Caffeine Assay to include measurement of caffeine as a parent drug.
The use of the current Emit® Caffeine Assav is limited to measurement of caffeine as a metabolite of Theophylline.
To support the broader intended use, a method comparison study was performed using 110 neonate samples with values spanning the assay range. Of these samples, thirty-one (31) were from patients who had received Theophylline and 79 were from patients who had received with Caffeine. The Assay results were compared to HPLC. The Emit® Caffeine Assay had excellent correlation with HPLC (correlation coefficient=0.99).
Other performance characteristics of the Emit® Caffeine Assay were previously established under K853872.
The Emit® Caffeine Assay, with broader intended use, is substantially equivalent to the current Emit® Caffeine Assay.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three wavy lines representing snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 8 2004
Ms. Yuk-Ting Lewis Regulatory Affairs and Compliance Manager Dade Behring, Inc PO Box 6101 M/S 514 Newark, DE 19714
Re: K042407
Trade/Device Name: Emit® Caffeine Assay Regulation Number: 21 CFR 862.3880 Regulation Name: Theophylline test system Regulatory Class: Class II Product Code: KLS Dated: September 1, 2004 Received: September 3, 2004
Dear Ms. Lewis:
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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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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, US. DVM.
Jean M. Cooper, MS. D.V.M. 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
510(k) Number (if known):
Emit® Caffeine Assay Device Name:
Indications For Use:
The Emit® Caffeine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of caffeine levels in human serum in subjects undergoing therapy with caffeine, especially in cases of neonatal apnea.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Robert Cates
Division Sign-Off
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Office of In Vitro Diagnostia Device Evaluation an
510(k) K042407