(116 days)
Not Found
No
The device description details a standard ELISA assay, which is a biochemical test and does not involve AI or ML. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
This device is an in vitro diagnostic assay used to monitor and predict the effectiveness of therapies by measuring bone resorption markers, rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "is intended for in vitro diagnostic use".
No
The device description clearly outlines a physical ELISA kit with reagents, antibodies, and a process involving pipetting, incubation, washing, and absorbance measurement. This is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "The Serum CrossLaps™ One Step ELISA assay is intended for in vitro diagnostic use". This is the primary indicator.
- Device Description: The description details a laboratory test (ELISA) performed on human plasma and serum samples to measure a specific biomarker (Type I Collagen C-Telopeptide). This is characteristic of an in vitro diagnostic test.
- Intended User/Care Setting: It is stated as "in vitro diagnostic use", further reinforcing its classification as an IVD.
- Performance Studies: The summary of performance studies describes clinical data demonstrating the assay's use in monitoring and predicting responses to therapies, which is a typical application for an IVD used in patient management.
- Predicate Device(s): The predicate device listed is also an "ELISA", which is a common type of in vitro diagnostic assay.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Serum CrossLaps™ One Step 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.
- 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
- 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 (comma separated list FDA assigned to the subject device)
JMM
Device Description
The Serum CrossLaps™ One Step ELISA kit was developed for the quantitative measurement of Type I Collagen C-Telopeptide (CrossLaps™) in human plasma and serum.
The EIA format is a non-competitive binding protein assay.
The Serum CrossLaps 114 One Step ELISA is based on two highly specific monoclonal antibodies against the amino acid sequence of EK AHD-B-GGR, where the aspartic acid residue (D) is ß-isomerized. In order to obtain a specific signal in the Serum CrossLaps 114 One Step ELISA, two chains of EK AHD-S-GGR must be cross-linked
Standards, control, or unknown serum samples are pipetted into the appropriate microtitre wells coated with streptavidin, followed by application of a mixture of a biotinylated antibody and a peroxidase-conjugated antibody. Then, a complex between CrossLaps 110 antigens, biotinylated antibody and peroxidase-conjugated antibody is generated, and this complex binds to the streptavidin surface via the biotinylated antibody. Following the one-step incubation at room temperature, the wells are emptied and washed. A chromogenic substrate is added and the colour reaction is stopped with sulfuric acid. Finally, the absorbance is measured at 450 nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human bone (implied from bone resorption)
Indicated Patient Age Range
postmenopausal women; individuals diagnosed with osteopenia
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 :
Monitoring bone resorption changes of A.
- 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
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): 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.
Not Found
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).
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
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the numbers '990843'. The handwriting style appears casual, with some variations in stroke thickness.
Summery of Safety and Effectiveness:
| Name of Device: | Serum CrossLaps™ One Step ELISA |
|---|---|
| Classification Name: | Enzyme immunoassay, Type I Collagen C-Telopeptide |
| Analyte Code and Name: | JMM |
| Submitter: | Osteometer BioTech A/S |
| Herlev Hovedgade 207 | |
| DK-2730 Herlev | |
| Date: | March 9th, 1999 |
The Serum CrossLaps™ One Step ELISA kit was developed for the quantitative measurement of Type I Collagen C-Telopeptide (CrossLaps™) in human plasma and serum.
The EIA format is a non-competitive binding protein assay.
The Serum CrossLaps 114 One Step ELISA is based on two highly specific monoclonal antibodies against the amino acid sequence of EK AHD-B-GGR, where the aspartic acid residue (D) is ß-isomerized. In order to obtain a specific signal in the Serum CrossLaps 114 One Step ELISA, two chains of EK AHD-S-GGR must be cross-linked
Standards, control, or unknown serum samples are pipetted into the appropriate microtitre wells coated with streptavidin, followed by application of a mixture of a biotinylated antibody and a peroxidase-conjugated antibody. Then, a complex between CrossLaps 110 antigens, biotinylated antibody and peroxidase-conjugated antibody is generated, and this complex binds to the streptavidin surface via the biotinylated antibody. Following the one-step incubation at room temperature, the wells are emptied and washed. A chromogenic substrate is added and the colour reaction is stopped with sulfuric acid. Finally, the absorbance is measured at 450 nm.
1
This pre-market notification demonstrates that the Serum CrossLaps™ One Step ELISA for the quantitative measurement of Type I Collagen C-telopeptides in plasma and serum is substantially equivalent to CrossLaps™ ELISA that was cleared by FDA in a previous submission (#K972788).
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.
- 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
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
...
2
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 circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles a triple helix or a series of flowing lines, often interpreted as representing the department's mission related to health and well-being.
JUL - 9 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Eva Gamwell Henriksen Head of Regulatory Affairs and Quality Assurance OSTEOMETER BIOTECH A/S HERLEV HOVEDGADE 207 DK-2730 HERLEV, DENMARK
Re: K990843
Trade Name: Serum CrossLaps™ One Step ELISA Regulatory Class: I reserved Product Code: JMM Dated: May 25, 1999 Received: May 27, 1999
Dear Ms. Henriksen:
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 (OS) 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.
3
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 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 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/dsma/dsmamain.html".
Sincerely yours,
Steven Gutman
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):_
Serum CrossLaps™ One Step ELISA Device Name:
Indications for use:
The Serum CrossLaps™ One Step 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.
- 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
- 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
Sean Cooper
(Division Sign-Off) (Division of Clinical Laborator) 89908
- Number PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription use
(Per 21 CFR 801.109)
✓
Over-The-Counter Use
(Optional Format 1-2-96)
0011