(123 days)
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No
The summary describes a standard enzymatic in vitro diagnostic assay for measuring 1,5-anhydroglucitol. There is no mention of AI, ML, or any computational analysis beyond standard data processing for quantitative measurement.
No.
A therapeutic device is used for treating or preventing diseases. This device is an in-vitro diagnostic test to monitor glycemic control in people with diabetes, not to treat them.
Yes
The "Intended Use / Indications for Use" section states that "The GlycoMark™ test... is indicated for the intermediate term monitoring of glycemic control in people with diabetes," which is a diagnostic purpose.
No
The device description clearly states it is a "fully automated enzymatic test" requiring "two-reagent boxed set" and a "15AG standard," indicating it is an in vitro diagnostic assay with physical reagents, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it provides quantitative measurement of a substance (1,5-anhydroglucitol) in a biological sample (serum or plasma) for the purpose of monitoring glycemic control in people with diabetes. This is a classic definition of an in vitro diagnostic test.
- Device Description: It describes reagents and standards used to perform an enzymatic test on serum or plasma, which are components of an in vitro diagnostic assay.
- Input Imaging Modality: It states "Not Applicable (In vitro diagnostic assay)", further confirming its nature.
- Anatomical Site: It states "Not Applicable (In vitro diagnostic assay using serum or plasma)", reinforcing that it's not applied directly to the body.
- Performance Studies: The performance studies describe analytical and clinical evaluations of the assay's performance in measuring the analyte in biological samples.
- Predicate Device: The predicate device listed is another IVD assay (Tina-Quant A1C Assay).
All these points strongly indicate that the GlycoMark™ test is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GlycoMark™ test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in serum or plasma. The test is for professional use, and is indicated for the intermediate term monitoring of glycemic control in people with diabetes.
Product codes (comma separated list FDA assigned to the subject device)
NOZ; JIS; JJX
Device Description
The GlycoMark™ reagents provide for a fully automated enzymatic test for 15AG. The assay requires the two-reagent boxed set (Reagent 1 and Reagent 2) and the 15AG standard (purchased separately). A two-level control set ("Low" and "High") is also available separately.
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
Professional use
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical data:
Evaluations were performed for analytical sensitivity, within-assay precision, between-assay precision, linearity, sample stability, and interfering substances.
- Analytical sensitivity: 0.2 µg/ml (estimated from 21 replicates of a saline reagent blank).
- Within-assay precision: 1.28 %CV to 3.83 %CV for 15AG levels of 4.6 ug/mL and 14.7 ug/mL.
- Between-assay precision: 0.79 %CV to 3.71 %CV for control samples and serum pool samples (concentrations from 4.7 ug/mL to 27.0 ug/mL).
- Linearity: Linear up to at least 110 ug/mL 15AG.
- Sample stability: Serum samples stable at room temperature or 2-8° C for up to seven days, and endure up to three freeze/thaw cycles.
- Interference: No effect from hemoglobin up to 125 mg/dL, triglycerides up to 1153 mg/dL, and bilirubin up to 53.3 mg/dL.
Clinical data:
- Study type: Prospective, longitudinal study.
- Sample size: 77 patients with diabetes (both type 1 and type 2).
- Key results: Patients had suboptimal glycemic control (A1C level ≥ 7%) at study entry and were monitored for eight weeks following initiation or modification of antihyperglycemic treatments. GlycoMark, A1C, fructosamine, and glucose measurements were performed every two weeks for the first four weeks and at Week 8. Significant changes vs. baseline appeared at Visit 2 for GlycoMark™, fructosamine, and glucose; whereas a significant change did not appear until Visit 3 for A1C.
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.
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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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§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the date SEP 22 2003. The text is in a bold, sans-serif font. The date is likely extracted from a document or photograph.
TOMEN
TOMEN AMERICA INC
1285 AVENUE OF THE AMERICA NEW YORK, N.Y. 10019-6028
TELEPHONE (212) 397-4600 FACSIMILE (212) 582-2007
510(k) SUMMARY
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 K031604.
| 807.92 (a)(1): Name: | Tomen America, Inc. |
|---|---|
| Address: | 1285 Avenue of the Americas |
| New York, NY 10019 | |
| Phone: | (212) 397-4600 |
| FAX: | (212) 582-2007 |
| Contact: | Mr. Shuhei Kato |
807.92 (a)(2): Device name- trade name and common name, and classification
| Trade name: | GlycoMark™ |
|---|---|
| Common Name: | 1,5-anhydroglucitol (15AG) Assay |
Classification: Assay, Glycosylated Hemoglobin; 21 CFR 864.7470
807.92 (a)(3): Identification of the legally marketed predicate device
GlycoMark™ is substantially equivalent to existing A1C assays, namely the Tina-Quant A1C Assay, K934070 (Roche Diagnostics Corporation, Indianapolis, IN). Both assay systems are indicated for use by people with diabetes to monitor glycemic control.
807.92 (a)(4): Device Description
The GlycoMark™ reagents provide for a fully automated enzymatic test for 15AG. The assay requires the two-reagent boxed set (Reagent 1 and Reagent 2) and the 15AG standard (purchased separately). A two-level control set ("Low" and "High") is also available separately.
Page 1 of 4
1
807.92 (a)(5): Intended Use
The GlycoMark™ test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in serum or plasma. The test is for professional use, and is indicated for the intermediate term monitoring of glycemic control in people with diabetes.
807.92 (a)(6): Technological Similarities and Differences to the Predicate
| Similarities / Differences Between GlycoMark™™ and A1C Assays | ||
|---|---|---|
| CHARACTERISTIC | GlycoMark™™ | Tina-Quant A1C |
| K934070 | ||
| Intended Use | Quantitative | |
| measurement of | ||
| 15AG in serum or | ||
| plasma | Quantitative measurement of the | |
| percent of glycated hemoglobin in | ||
| whole blood | ||
| Indications for Use | Indicated for the | |
| intermediate term | ||
| monitoring of | ||
| glycemic control in | ||
| people with diabetes | Used in the management and | |
| treatment of diabetes, for monitoring | ||
| long term glycemic control | ||
| Risk to Patient | Not a critical analyte |
- reflects glucose
monitoring over time | Not a critical analyte - reflects glucose
monitoring over time |
| Sample | Serum or plasma | Whole blood |
| Sample Preparation | Standard processing
for serum or plasma | Prepare hemolysate with hemolyzing
reagent |
| Calibration | Parameters and
calibration factors
provided by
instrumentation
company | Parameters and calibration factors
provided by instrumentation company |
| Methodology | Colorimetric assay;
sample plus the
addition of Reagent 1
(pretreatment) and
Reagent 2 (color
reagent) | Turbidimetric inhibition immunoassay
for hemolyzed whole blood |
| Detection Method/
Throughput | System adapted for
high-throughput,
laboratory analyzers,
e.g., Hitachi 917 | System adapted for high-throughput,
laboratory analyzers, e.g., Hitachi 917 |
| Testing Environment | Professional use | Professional use |
| Precision | Intra-run %CVs
between 1% and 4%,
between-day %CVs
between 1% and 4% | Intra-run %CVs less than 2%,
between-day %CVs between 3% and
4% |
2
807.92 (b)(1): Brief Description of Nonclinical Data
Evaluations were performed for analytical sensitivity, within-assay precision, between-assay precision, linearity, sample stability, and interfering substances. Those resulting data are summarized below.
To determine the analytical sensitivity, twenty-one replicates of a saline reagent blank were analyzed as unknowns in one assay run. The analytical sensitivity is estimated to be 0.2 µg/ml, and this is defined as the mean 15AG concentration plus one standard deviation.
Within-assay precision, when evaluated at two levels of 15AG (low- 4.6 ug/mL) and high- 14.7 ug/mL), ranged from 1.28 %CV to 3.83 %CV. Between assay precision, when evaluated with two control samples and two serum pool samples (concentrations from 4.7 ug/mL to 27.0 ug/mL) ranged from 0.79 %CV to 3.71 %CV.
Results from linearity studies demonstrated that the GlycoMark™ test is linear up to at least 110 ug/mL 15AG. Results from sample stability studies demonstrated that serum samples may be stored at room temperature or at 2-8° C for up to seven days prior to analysis, and may endure up to three freeze/thaw cycles prior to analysis.
Results from interference testing showed that the GlycoMark™ test is not affected by hemoglobin up to 125 mg/dL (in the case of hemolyzed samples), triglycerides up to 1153 mg/dL (in the case of lipemic samples), and bilirubin up to 53.3 mg/dL (in the case of icteric samples).
807.92 (b)(2): Brief Description of Clinical Data
A prospective, longitudinal study was performed with 77 patients with diabetes (both type 1 and type 2). The patients exhibited suboptimal glycemic control (A1C level greater than or equal to 7%) at study entry, and these patients were monitored for eight weeks following initiation or modification of antihyperglycemic treatments. Measurements for GlycoMark, A1C, fructosamine, and glucose were performed every two weeks for the first four weeks (Visits 1-3) and then at Week 8 (Visit 4).
3
The figure presents the mean values for each marker by visit. An asterisk (*) denotes significant changes vs. baseline values (p K031604 Trade/Device Name: GlycoMarkTM Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: NOZ: JIS; JJX Dated: August 29, 2003 Received: September 2, 2003
Dear Ms. Ammirati:
Re:
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 (OS) 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 (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,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
STATEMENT OF INTENDED USE
510(K) Number (if known): K031604
Device Name: GlycoMark™
Indications for Use:
The GlycoMark™ test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in serum or plasma. The test is for professional use, and is indicated for the intermediate term monitoring of glycemic control in people with diabetes.
. /
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE AS NEEDED)
| Prescription Use
(Per 21 CFR 801.109)
| ✓ | OR | Over -the-Counter Use __ |
|---|---|---|
| ----------------------------------------------- | ---- | -------------------------- |
Division Sign-Off
for Ican Cooper
Office of In Vitro Diagnostic Device
Evaluation and SafetyKO3
1604
510(k).