(74 days)
This in vitro diagnostic method is intended to quantitatively measure deoxypyridinoline (DPD) in human urine on the Bayer Immuno 1™ system. Measurements obtained by this device are used as an indicator of bone resorption. Results obtained using the Bayer Immuno 1 system Deoxypyridinoline method are generally expressed as a ratio to urine creatinine (nM DPD/mM creatinine), and should be interpreted in conjunction with all other available clinical and diagnostic results. The urine creatinine result (mmol/L) must be entered from an off-system standard laboratory analysis.
This diagnostic method is not intended for use on any other system.
The IMMUNO 1 DPD assay is a heterogeneous competitive immunoassay format.
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied/Direct) | Reported Device Performance (Bayer Immuno 1™ DPD assay) |
|---|---|---|
| Sensitivity (Minimum Detectable Concentration) | Not explicitly stated, but typically lower is better. | 0.8 nM |
| Imprecision (Within Run CV) | Not explicitly stated. | Varies by DPD concentration; details in "IMPRECISION of IMMUNO 1 DPD Method" table. |
| Imprecision (Total CV) | Not explicitly stated. | Varies by DPD concentration; details in "IMPRECISION of IMMUNO 1 DPD Method" table. |
| Method Comparison (Correlation with Predicate Device) | Not explicitly stated, but high correlation (r-value close to 1) is expected. | n=341, Regression details vary by range, but an 'r' value is given for each; overall good correlation with Pyrilinks®-D. |
| Recovery | Range of 96-104% (common industry standard for recovery studies, though not explicitly stated as acceptance criteria here). | 96% to 110%, with an average of 101.7% ± 3.8% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Method Comparison: 341 human urine samples.
- Sample Size for Imprecision: 3 controls, assayed in duplicate for 20 runs (40 assays total).
- Sample Size for Recovery: 11 urine samples.
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It refers to "human urine samples," which could imply prospective collection for validation, but this is not confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not describe the use of experts to establish ground truth for the test set. Instead, the "ground truth" for method comparison and recovery studies is based on quantitative analytical results from the predicate device (Pyrilinks®-D method) or known spiked concentrations.
4. Adjudication Method for the Test Set
Not applicable. This device validation focuses on analytical performance characteristics (sensitivity, imprecision, correlation with a predicate device, recovery) rather than subjective assessments requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or interpretation device. Therefore, MRMC studies and assessment of human reader improvement with AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are essentially standalone performance evaluations of the IMMUNO 1 DPD assay. The reported metrics (sensitivity, imprecision, method comparison, and recovery) are specific to the device's analytical capabilities without human interpretative input beyond operating the system and entering creatinine results.
7. The Type of Ground Truth Used
- For Method Comparison: The "ground truth" was the quantitative results obtained from the predicate device, Pyrilinks®-D method. This is a comparative study of two analytical methods.
- For Recovery: The "ground truth" was the known concentration of DPD spiked into urine samples.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This is a traditional in vitro diagnostic device, not an AI/ML-based system. Therefore, the concept of a training set as understood in AI development is not applicable here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/ML model for this traditional in vitro diagnostic device.
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SEP 22 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter:
Gabriel
7/7
Mr. Gabriel J. Muraca, Jr.
Manager, Regulatory Affairs
Bayer Diagnostics
511 Benedict Avenue
Tarrytown, New York 10591-5097
- DEVICE: Deoxypvridinoline Assay for the Bayer Immuno 1™ System
PREDICATE DEVICE:
| Name: | Pyrilinks® -D |
|---|---|
| Manufacturer: | Metra Biosystems, Inc. Mountain View, CA |
INTENDED USE
This in vitro diagnostic method is intended to quantitatively measure deoxypyridinoline (DPD) in human urine on the Bayer Immuno 1™ system. Measurements obtained by this device are used as an indicator of bone resorption. Results obtained using the Bayer Immuno 1 system Deoxypyridinoline method are generally expressed as a ratio to urine creatinine (nM DPD/mM creatinine), and should be interpreted in coniunction with all other available clinical and diagnostic results. The urine creatinine result (mmol/L) must be entered from an off-system standard laboratory analysis.
PRINCIPLE OF THE PROCEDURE
The IMMUNO 1 DPD assay is a heterogeneous competitive immunoassay format.
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PERFORMANCE CHARACTERISTICS
Sensitivity: Minimum Detectable Concentration
The minimum detectable concentration is 0.8 nM. This is a multisystem estimate of two times the within run standard deviation of the zero calibrator.
Imprecision
Within run and total imprecision were evaluated for the IMMUNO 1 DPD assay over a 10 day period using two IMMUNO 1 instruments (20 runs total). Three controls were assayed in duplicate for each run making a total of 40 assays. The results are summarized in the following table:
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|---|---|---|---|---|
| 787 |
IMPRECISION of IMMUNO 1 DPD Method
Method Comparison
A total of 341 human urine samples were assayed by the IMMUNO 1 DPD method and the Pyrilinks® -D method. Urine samples were clarified by centrifugation prior to assay on the IMMUNO 1. The following table lists the correlation results:
CORRELATION DATA
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|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Recovery
Eleven urine samples with endogenous DPD levels ranging from 0 nM to 158,5 nM were spiked with 100 nM DPD and the recovered DPD was determined using the IMMUNO 1 DPD method. The recovery results ranged from 96% to 110% with an average of 101.7% ± 3.8%.
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Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle, with its wings spread and its head turned to the right.
SEP 2 2 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Gabriel J. Muraca, Jr. . Manaqer, Requlatory Affairs Bayer Diaqnostics 511 Benedict Avenue Tarrytown, NY 10591-5097
Re : K972580/S1 Deoxypyridinoline Assay for the Bayer Immuno 1™ System Regulatory Class: II Product Code: JMM, JIS, JJX Dated: September 10, 1997 Received: September 11, 1997
Dear Mr. Muraca
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. A 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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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 requlation (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 Sitman
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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Attachment 7
Page 1 of 1
510(k) Number (if known):
Device Name:
Deoxypyridinoline (DPD)
Indications For Use:
This in vitro diagnostic method is intended to quantitatively measure deoxypyridinoline (DPD) in human urine on the Bayer Immuno 1™ system. Measurements obtained by this device are used as an indicator of bone resorption. Results obtained using the Bayer Immuno 1 system Deoxypyridinoline method are generally expressed as a ratio to urine creatinine (nM DPD/mM creatinine), and should be interpreted in conjunction with all other available clinical and diagnostic results. The urine creatinine result (mmoVL) must be entered from an off-system standard laboratory analysis.
This diagnostic method is not intended for use on any other system.
EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF EDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carl Benson for Alfred Montgomery
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K972580 |
|---|---|
| --------------- | --------- |
| Prescription Use(Per 21 CFR 801.109) | OR Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|
| ------------------------------------------ | ----------------------------------------------------- |
§ 862.1400 Hydroxyproline test system.
(a)
Identification. A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.