(512 days)
Not Found
No
The device description details a standard ELISA assay, which is a biochemical test, and there is no mention of AI or ML in the intended use, device description, or any other section.
No.
The device is an in vitro diagnostic assay used to measure bone resorption, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "CrossLaps™ ELISA assay is intended for in vitro diagnostic use."
No
The device description clearly states it is an ELISA kit, which is a laboratory assay involving physical reagents and a spectrophotometer for analysis, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The CrossLaps™ ELISA assay is intended for in vitro diagnostic use..."
- Nature of the Test: The device description details a laboratory test (ELISA) performed on a human sample (urine) to measure a specific analyte (Type I Collagen C-Telopeptide). This is the definition of an in vitro diagnostic test.
- Intended User/Care Setting: The "Intended User / Care Setting" section also explicitly states "in vitro diagnostic use".
- Purpose: The intended use describes how the results of the test are used to aid in the diagnosis and monitoring of bone conditions and therapies, which is a core function of an IVD.
N/A
Intended Use / Indications for Use
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
2. ) Anti-resorptive therapies in individuals diagnosed with osteopenia;
a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
b) Bisphosphonate therapies
3. } 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
Product codes
JMM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human bone
Indicated Patient Age Range
postmenopausal women, individuals diagnosed with osteopenia, individuals diagnosed with Paget's disease of bone
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)
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 :
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
2. ) Anti-resorptive therapies in individuals diagnosed with osteopenia;
a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
b) Bisphosphonate therapies
3. } 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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): | K972788
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|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | |
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