(512 days)
The CrossLaps™ ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption and may be used as an aid in :
A. Monitoring bone resorption changes of
- ) Anti-resorptive therapies in postmenopausal women:
a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
b) Bisphosphonate therapies - ) Anti-resorptive therapies in individuals diagnosed with osteopenia;
a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
b) Bisphosphonate therapies - } Anti-resorptive therapies in individuals diagnosed with Paget's disease of bone
B. Predicting skeletal Response (Bone Mineral Density) in postmenopausal woman under going anti-resorptive therapies
a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
b) Bisphosphonate therapies
The CrossLaps™ ELISA kit was developed for the quantitative measurement of Type I Collagen C-Telopeptide (CrossLaps™) in human urine. The EIA format is a competitive binding protein assay. CrossLaps™ in the urine competes with the antigen coated to the microtitration wells for the enzyme labeled antibody displacing it from binding to the antigen coated wells. Separation of free form the bound CrossLaps™ is achieved by washing the well. The resultant is analyzed in a spectrophotometer for absorbance The amount of enzyme labeled CrossLaps™ present in the sample.
The provided text describes the CrossLaps™ ELISA kit, an in vitro diagnostic device for measuring Type I Collagen C-Telopeptide in human urine, and its expanded indications for use. However, the document (K972788) is a 510(k) pre-market notification that demonstrates substantial equivalence to a previously cleared device (K960171), rather than a detailed study report proving the device meets specific acceptance criteria based on performance studies.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not explicitly present in the provided text. The document focuses on the unchanged nature of the device's technical and clinical performance despite a minor component change (one-component TMB instead of two-component TMB) from its predicate device. It also outlines the expanded indications for use that were supported by "clinical data" but does not detail that data.
Based on the information available:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states:
"The technical and clinical performance of the device is not influenced by this substitution and no issues of safety and effectiveness are raised by this change."
This implies that the previous performance (of the predicate device K960171) was considered acceptable, and the minor change to the TMB substrate did not alter that performance. However, specific performance metrics or acceptance criteria are not quantified.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided. The document mentions "clinical data demonstrating that The CrossLaps™ ELISA assay is intended for in vitro diagnostic use..." but does not elaborate on the sample size, design, or provenance of this clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided. As the document is a 510(k) for substantial equivalence and expanded indications rather than a detailed performance study, it does not include specifics about expert adjudication or ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided.
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:
This information is not applicable/provided. The CrossLaps™ ELISA is an in vitro diagnostic assay, not an imaging device or AI-assisted diagnostic tool that would involve multi-reader studies or human-in-the-loop performance measurement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable/provided. As an ELISA kit, this device performs a biochemical measurement and doesn't involve an "algorithm" in the sense of AI or image interpretation. Its performance is inherent to the assay's chemical and biological interactions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided. For an in vitro diagnostic measuring a biomarker, the "ground truth" would typically involve correlation with clinical status, disease progression, or response to therapy, often established through clinical endpoints or reference methods. The document states the assay is "an indication of human bone resorption" and "an aid in monitoring bone resorption changes" and "Predicting skeletal Response (Bone Mineral Density)". This implies its performance is validated against these clinical outcomes or established markers. However, the specifics of how this ground truth was derived for any supporting clinical data are not detailed.
8. The sample size for the training set:
This information is not provided. ELISA kits do not typically have a "training set" in the same way machine learning models do. The development and validation of such assays involve different types of studies (e.g., analytical validation for sensitivity, specificity, accuracy, precision, linearity, and clinical validation for correlation with disease/outcomes). The document refers to "clinical data" but doesn't elaborate on its nature or sample size.
9. How the ground truth for the training set was established:
This information is not provided and is largely not applicable in the context of an ELISA assay's development.
In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence for an expanded indication for use, not a detailed scientific study report. It states that the device's performance is unchanged from its predicate despite a minor component alteration, but it does not detail the specific performance metrics, acceptance criteria, or the studies that would formally establish these for the current or predicate device.
{0}------------------------------------------------
DEC 22 1998
K972788
Summery of Safety and Effectiveness:
| Name of Device: | CrossLaps™ ELISA | |
|---|---|---|
| Classification Name: | Enzyme immunoassay, Type I Collagen C-Telopeptide | |
| Analyte Code and Name: | Type I Collagen C-Telopeptide | |
| Submitter: | Osteometer BioTech A/S | |
| Herlev Hovedgade 207 | ||
| DK-2730 Herlev | ||
| Contact person | Eva Gamwell Henriksen | |
| Date: | December 16th, 1998 |
The CrossLaps™ ELISA kit was developed for the quantitative measurement of Type I Collagen C-Telopeptide (CrossLaps™) in human urine.
The EIA format is a competitive binding protein assay.
CrossLaps™ in the urine competes with the antigen coated to the microtitration wells for the enzyme labeled antibody displacing it from binding to the antigen coated wells. Separation of free form the bound CrossLaps™ is achieved by washing the well. The resultant is analyzed in a spectrophotometer for absorbance The amount of enzyme labeled CrossLaps™ present in the sample.
The reason for the present submission is to expand the indications of the device.
This pre-market notification demonstrates that the CrossLaps™ ELISA for the quantitative measurement of Type I Collagen C-telopeptides is substantially equivalent to the DSL Active™ CrossLaps™ ELISA that was cleared by FDA in a previous submission (#K960171).
The manufacture and specification of the device remains unchanged form those of the predicate device (#K960171). Only one minor change in components and procedure has occurred: the submitted CrossLaps™ ELISA kit uses one-component TMB substrate for staining of bound secondary antibody instead of two-component TBM as used in the predicate device (#K960171).
The substitution (one-component for two-component TMB) was carried out to obtain a more safe and user friendly working procedure for the customer.
The technical and clinical performance of the device is not influenced by this substitution and no issues of safety and effectiveness are raised by this change.
The intended use of CrossLaps™ ELISA remains unchanged form the previous device with respect to analyte being measured. (Type I Collagen C-Telopeptide) and the specimen matrix (human urine).
{1}------------------------------------------------
The only change in the intended use is the indication for the device.
This pre-market notification includes clinical data demonstrating that
The CrossLaps™ ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption and may be used as an aid in :
Monitoring bone resorption changes of A.
-
- ) Anti-resorptive therapies in postmenopausal women:
- a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
- b) Bisphosphonate therapies
-
- ) Anti-resorptive therapies in individuals diagnosed with osteopenia;
- a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
- b) Bisphosphonate therapies
-
- } Anti-resorptive therapies in individuals diagnosed with Paget's disease of bone
- B. Predicting skeletal Response (Bone Mineral Density) in postmenopausal woman under going anti-resorptive therapies
- a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
- b) Bisphosphonate therapies
000027
年度5一
{2}------------------------------------------------
DEC 22 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Devices and Diagnostics Consulting Group Tom Tsakaris C/O Osteometer Biotech A/S 16809 Briardale Road Rockville, MD 20855
Re: K972788
Trade Name: CrossLaps™ ELISA Regulatory Class: I Product Code: JMM Dated: October 19, 1998 October 21, 1998 Received:
Dear Mr. Tsakaris:
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 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). 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 Regulations, 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 requlation 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.
{3}------------------------------------------------
Paqe 2
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 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 requlation 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/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
{4}------------------------------------------------
| 510(k) Number (if known): | K972788shabitate follower to material direktor adus "o ales for to tre to tre to tre result of the Ports Portugious aand the mail and and the collection of the states and the states and the many of the may be any comments of the comments of the comments of the comments of the comments of thand and the program and program and the first of the first of the first and the first and the first and the first and the first and the first and the first and the first and | |
|---|---|---|
Device Name: CrossLaps™ ELISA
Indications for use:
B.
The CrossLaps™ ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption and may be used as an aid in :
| A. | Monitoring bone resorption changes of |
|---|---|
| 1.) Anti-resorptive therapies in postmenopausal women: | |
| a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs | |
| b) Bisphosphonate therapies |
-
- ) Anti-resorptive therapies in individuals diagnosed with osteopenia;
- a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
- b) Bisphosphonate therapies
- ) Anti-resorptive therapies in individuals diagnosed with Paget's disease of bone
Predicting skeletal Response (Bone Mineral Density) in postmenopausal woman under going anti-resorptive therapies
a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
- b) Bisphosphonate therapies
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
なみー
Theronica J. Melvin for Law Montgomery
Division Sign-Off
Division of Clinical Laboratory Devices
510(k) Number K972188
000028
§ 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.